Clinical Trials

As part of the development process, our products are evaluated in clinical trials to find new and better ways to diagnose and treat disease. These studies may be sponsored by Advanced Accelerator Applications (AAA) or by independent investigators/physicians at medical centers. Products tested in clinical trials may not be approved by health authorities, or they may be approved for certain indications but being tested to determine if they are useful in other conditions. Patients should discuss their potential participation in such studies with their physician.

Ongoing Clinical Studies with Advanced Accelerator Applications Pipeline Candidates

Study Name/Title Study Number Sponsor Phase Disease State Treatment Center(s) Lead PI

Lu 177 Therapeutics

LUTETIUM LU 177 DOTATATE / LUTETIUM 177LU OXODOTREOTIDE
Netter-1: Study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive midgut carcinoid tumors
NCT01578239 AAA III Inoperable, progressive, somatostatin receptor positive midgut carcinoid tumors lutetium Lu 177 dotatate vs Octreotide LAR
  • 14 US sites
  • 27 European sites (Belgium, France, Germany, Italy, Portugal, Spain, UK)
Dr. Jonathan Strosberg
Netter-1
Study Name/Title Netter-1: Study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive midgut carcinoid tumors
Study Number NCT01578239
Sponsor AAA
Phase III
Disease State Inoperable, progressive, somatostatin receptor positive midgut carcinoid tumors
Treatment lutetium Lu 177 dotatate vs Octreotide LAR
Center(s)
  • 14 US sites
  • 27 European sites (Belgium, France, Germany, Italy, Portugal, Spain, UK)
Lead PI Dr. Jonathan Strosberg
OCLURANDOM: Antitumor efficacy of PRRT with 177Lutetium Octreotate randomized vs sunitinib in unresectable progressive well-differentiated neuroendocrine pancreatic tumors
NCT02230176 Gustave Roussy Institute (France) II Progressive unresectable pNETs lutetium Lu 177 dotatate vs Sutent
  • Gustave Roussy Institute (France),
  • CHU Lyon (France),
  • CHU Nantes (France),
  • CHU Marseille Timone (France),
  • CHU Marseille Nord (France),
  • Institut Claudius Regaud (France),
  • CHU Rangueil (France)
Prof. Eric Baudin, Gustave Roussy Institute
OCLURANDOM
Study Name/Title OCLURANDOM: Antitumor efficacy of PRRT with 177Lutetium Octreotate randomized vs sunitinib in unresectable progressive well-differentiated neuroendocrine pancreatic tumors
Study Number NCT02230176
Sponsor Gustave Roussy Institute (France)
Phase II
Disease State Progressive unresectable pNETs
Treatment lutetium Lu 177 dotatate vs Sutent
Center(s)
  • Gustave Roussy Institute (France),
  • CHU Lyon (France),
  • CHU Nantes (France),
  • CHU Marseille Timone (France),
  • CHU Marseille Nord (France),
  • Institut Claudius Regaud (France),
  • CHU Rangueil (France)
Lead PI Prof. Eric Baudin, Gustave Roussy Institute
LuDo: A phase IIa trial of lutetium Lu 177 dotatate in children with primary refractory or relapsed high risk neuroblastoma
EudraCT N°: 2012-000510-10 University of Birmingham (UK) II Primary refractory or relapsed high risk neuroblastoma lutetium Lu 177 dotatate
  • University College London Hospitals (UK)
Dr. Mark Gaze, University College London Hospitals
LuDo
Study Name/Title LuDo: A phase IIa trial of lutetium Lu 177 dotatate in children with primary refractory or relapsed high risk neuroblastoma
Study Number EudraCT N°: 2012-000510-10
Sponsor University of Birmingham (UK)
Phase II
Disease State Primary refractory or relapsed high risk neuroblastoma
Treatment lutetium Lu 177 dotatate
Center(s)
  • University College London Hospitals (UK)
Lead PI Dr. Mark Gaze, University College London Hospitals
LUCAS: 177Lutetium – PRRT (Lu-PRRT) plus Capecitabine versus Lu-PRRT in FDG positive, gastro-entero- pancreatic neuroendocrine tumors
NCT02736448 IRST Meldola (Italy) II FDG positive GEP-NET tumors lutetium Lu 177 dotatate vs Lu+Capecitabine
  • IRST, Meldola (Italy)
Prof. Giovanni Paganelli, IRST
LUCAS
Study Name/Title LUCAS: 177Lutetium – PRRT (Lu-PRRT) plus Capecitabine versus Lu-PRRT in FDG positive, gastro-entero- pancreatic neuroendocrine tumors
Study Number NCT02736448
Sponsor IRST Meldola (Italy)
Phase II
Disease State FDG positive GEP-NET tumors
Treatment lutetium Lu 177 dotatate vs Lu+Capecitabine
Center(s)
  • IRST, Meldola (Italy)
Lead PI Prof. Giovanni Paganelli, IRST
LUNET: PRRT with radiolabelled somatostatin analogue lutetium Lu 177 dotatate in advanced GEP-NET, FDG-PET negative patients
NCT02489604 IRST Meldola (Italy) II Advanced GEP-NETs (FDG neg) lutetium Lu 177 dotatate
  • IRST, Meldola (Italy)
Dr. Maddalena Sansovini, IRST
LUNET
Study Name/Title LUNET: PRRT with radiolabelled somatostatin analogue lutetium Lu 177 dotatate in advanced GEP-NET, FDG-PET negative patients
Study Number NCT02489604
Sponsor IRST Meldola (Italy)
Phase II
Disease State Advanced GEP-NETs (FDG neg)
Treatment lutetium Lu 177 dotatate
Center(s)
  • IRST, Meldola (Italy)
Lead PI Dr. Maddalena Sansovini, IRST
LUTHREE: Randomized trial in SSTR2 positive tumors to optimize the interval between cycles of PRRT with lutetium Lu 177 dotatate
EudraCT N°: 2015-004727-31 IRST Meldola (Italy) II SSTR2 positive tumors lutetium Lu 177 dotatate
  • IRST, Meldola (Italy)
Dr. Stefano Severi, IRST
LUTHREE
Study Name/Title LUTHREE: Randomized trial in SSTR2 positive tumors to optimize the interval between cycles of PRRT with lutetium Lu 177 dotatate
Study Number EudraCT N°: • IRST, Meldola (Italy) 2015-004727-31
Sponsor IRST Meldola (Italy)
Phase II
Disease State SSTR2 positive tumors
Treatment lutetium Lu 177 dotatate
Center(s)
  • IRST, Meldola (Italy)
Lead PI Dr. Stefano Severi, IRST
Lutetium Lu 177 dotatate in therapy of inoperable pheochromocytoma (PHEO)/paraganglioma (PGL)
NCT03206060 NCI-NIH (USA) II Inoperable, SSTR positive PHEO/PGL lutetium Lu 177 dotatate
  • MIP/CCR/NCI, Medical Center, Bethesda, MD (USA)
Dr. Frank Lin, NCI
Lutetium Lu 177 dotatate
Study Name/Title Lutetium Lu 177 dotatate in therapy of inoperable pheochromocytoma (PHEO)/paraganglioma (PGL)
Study Number NCT03206060
Sponsor NCI-NIH (USA)
Phase II
Disease State Inoperable, SSTR positive PHEO/PGL
Treatment lutetium Lu 177 dotatate
Center(s)
  • MIP/CCR/NCI, Medical Center, Bethesda, MD (USA)
Lead PI Dr. Frank Lin, NCI
Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for patients with extensive-stage small cell lung cancer
NCT03325816 Georgetown University Medical Center
(USA)
I/II Small cell lung cancer/extensive stage Nivolumab and lutetium Lu 177 dotatate
  • Georgetown University Medical Center, Washington D.C (USA)
Dr. Giuseppe Giaccone, Georgetown University Medical Center
Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate
Study Name/Title Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for patients with extensive-stage small cell lung cancer
Study Number NCT03325816
Sponsor Georgetown University Medical Center (USA)
Phase I/II
Disease State Small cell lung cancer/extensive stage
Treatment Nivolumab and lutetium Lu 177 dotatate
Center(s)
  • Georgetown University Medical Center, Washington D.C (USA)
Lead PI Dr. Giuseppe Giaccone, Georgetown University Medical Center
PREELU: Prediction of radio-exposure induced by patients treated by lutetium Lu 177 dotatate
NA Association Robert Debré (France) Observational Radiation exposure following Temporary Authorization of Use in midgut NETs lutetium Lu 177 dotatate
  • Hôpital Saint Antoine - APHP (France)
Dr. Jules Zhang-Yin, Hôpital Saint Antoine - APHP
PREELU
Study Name/Title PREELU: Prediction of radio-exposure induced by patients treated by lutetium Lu 177 dotatate
Study Number NA
Sponsor Association Robert Debré (France)
Phase Observational
Disease State Radiation exposure following Temporary Authorization of Use in midgut NETs
Treatment lutetium Lu 177 dotatate
Center(s)
  • Hôpital Saint Antoine - APHP (France)
Lead PI Dr. Jules Zhang-Yin, Hôpital Saint Antoine - APHP
PSMA-R2
PROter: 177Lu-PSMA-R2 in patients with positive progressive, metastatic, castration resistant prostate cancer
NCT03490838 Eudra CT N°: 2017-004034-29 AAA I/II Positive progressive, metastatic, castration resistant prostate cancer 177Lu-PSMA-R2
  • Phoenix Molecular Imaging, Phoenix, AZ (USA)
Dr. Fabio Almeida, Phoenix Molecular Imaging
PSMA-R2
Study Name/Title PROter: 177Lu-PSMA-R2 in patients with positive progressive, metastatic, castration resistant prostate cancer
Study Number NCT03490838 Eudra CT N°: 2017-004034-29
Sponsor AAA
Phase I/II
Disease State Positive progressive, metastatic, castration resistant prostate cancer
Treatment 177Lu-PSMA-R2
Center(s)
  • Phoenix Molecular Imaging, Phoenix, AZ (USA)
Lead PI Dr. Fabio Almeida, Phoenix Molecular Imaging
NEOBOMB1
NeoTER: Phase Ia-Ib trial of 177Lu-NeoBOMB1 in subjects with tumors expressing Gastrin Releasing Peptide Receptor (GRPR)
Eudra CT N°: 2017-005069-36 AAA Ia/Ib Positive relapsed or refractory metastatic breast and prostate cancer 177Lu-NeoBOMB1
  • Medical University Innsbruck (Austria)
  • University of Bordeaux (France)
  • University of Grenoble (France)
  • Erasmus Medical Center (The Netherlands)
Prof. Irene Virgolini, Medical University Innsbruck
Prof. Elif Hindié, University of Bordeaux
Dr. Loic Djaileb, University of Grenoble
Prof. Astrid Van Der Velt, Erasmus Medical Center
NEOBOMB1
Study Name/Title NeoTER: Phase Ia-Ib trial of 177Lu-NeoBOMB1 in subjects with tumors expressing Gastrin Releasing Peptide Receptor (GRPR)
Study Number Eudra CT N°: 2017-005069-36
Sponsor AAA
Phase Ia/Ib
Disease State Positive relapsed or refractory metastatic breast and prostate cancer
Treatment 177Lu-NeoBOMB1
Center(s)
  • Medical University Innsbruck (Austria)
  • University of Bordeaux (France)
  • University of Grenoble (France)
  • Erasmus Medical Center (The Netherlands)
Lead PI Prof. Irene Virgolini, Medical University Innsbruck
Prof. Elif Hindié, University of Bordeaux
Dr. Loic Djaileb, University of Grenoble
Prof. Astrid Van Der Velt, Erasmus Medical Center

Ga 68 PET Diagnostics

GALLIUM GA 68 DOTATATE
The diagnostic value of Ga 68 dotatate PET/CT in patients with cardiac sarcoidosis
in process Columbia University Medical Center (USA) I/II Cardiac sarcoidosis Diagnostic
  • Columbia University Medical Center, New York, NY (USA)
Dr. Sabahat Bokhari, Columbia University Medical Center
GALLIUM GA 68 DOTATATE
Study Name/Title The diagnostic value of Ga 68 dotatate PET/CT in patients with cardiac sarcoidosis
Study Number in process
Sponsor Columbia University Medical Center (USA)
Phase I/II
Disease State Cardiac sarcoidosis
Treatment Diagnostic
Center(s)
  • Columbia University Medical Center, New York, NY (USA)
Lead PI Dr. Sabahat Bokhari, Columbia University Medical Center
Gallium Ga 68 Dotatate: PET/CT in diagnosing patients with metastatic castration resistant prostate cancer
NCT03448458 Emory University (USA) II Metastatic castration resistant prostate carcinoma Diagnostic
  • Emory University Hospital Atlanta, GA (USA)
Dr. Mehmet Asim Bilen, Emory University
Gallium Ga 68 Dotatate
Study Name/Title Gallium Ga 68 Dotatate: PET/CT in diagnosing patients with metastatic castration resistant prostate cancer
Study Number NCT03448458
Sponsor Emory University (USA)
Phase II
Disease State Metastatic castration resistant prostate carcinoma
Treatment Diagnostic
Center(s)
  • Emory University Hospital Atlanta, GA (USA)
Lead PI Dr. Mehmet Asim Bilen, Emory University
PSMA-R2
PROfind: 68Ga-PSMA-R2 in patients with biochemical relapse and metastatic prostate cancer
NCT03490032 AAA I/II Biochemical relapse and metastatic prostate cancer Diagnostic
  • Phoenix Molecular Imaging, Phoenix, AZ (USA)
Dr. Fabio Almeida, Phoenix Molecular Imaging
PSMA-R2
Study Name/Title PROfind: 68Ga-PSMA-R2 in patients with biochemical relapse and metastatic prostate cancer
Study Number NCT03490032
Sponsor AAA
Phase I/IIì
Disease State Biochemical relapse and metastatic prostate cancer
Treatment Diagnostic
Center(s)
  • Phoenix Molecular Imaging, Phoenix, AZ (USA)
Lead PI Dr. Fabio Almeida, Phoenix Molecular Imaging
NEOBOMB1
MITIGATE: Study to evaluate 68Ga NeoBOMB1 PET/CT in patients with advanced TKI-treated gastrointestinal stromal tumors (GIST)
EudraCT N°: 2016-002053-38 Medical University Innsbruck (Austria) I/IIa Advanced TKI-treated GIST Diagnostic
  • Medical University Innsbruck (Austria)
Prof. Irene Virgolini, Medical University Innsbruck
NEOBOMB1
Study Name/Title MITIGATE: Study to evaluate 68Ga NeoBOMB1 PET/CT in patients with advanced TKI-treated gastrointestinal stromal tumors (GIST)
Study Number EudraCT N°: 2016-002053-38
Sponsor Medical University Innsbruck (Austria)
Phase I/IIa
Disease State Advanced TKI-treated GIST
Treatment Diagnostic
Center(s)
  • Medical University Innsbruck (Austria)
Lead PI Prof. Irene Virgolini, Medical University Innsbruck
NeoFIND: 68Ga-NeoBOMB1 imaging in patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor (GRPR)
Eudra CT N°: 2017-003432-37 AAA II Relapsed or refactory metastatic luminal breast cancer, adenocarcinoma of prostate, small cell lung cancer, non-small cell lung cancer, colorectal carcinoma Diagnostic
  • Medical University Innsbruck (Austria)
  • University of Bordeaux (France)
  • University of Grenoble (France)
  • Erasmus Medical Center (The Netherlands)
Prof. Irene Virgolini, Medical University Innsbruck
Prof. Philippe Fernandez, University of Bordeaux
Dr. Loic Djaileb, University of Grenoble
Prof. Astrid Van Der Velt, Erasmus Medical Center
NeoFIND
Study Name/Title NeoFIND: 68Ga-NeoBOMB1 imaging in patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor (GRPR)
Study Number Eudra CT N°: 2017-003432-37
Sponsor AAA
Phase II
Disease State Relapsed or refactory metastatic luminal breast cancer, adenocarcinoma of prostate, small cell lung cancer, non-small cell lung cancer, colorectal carcinoma
Treatment Diagnostic
Center(s)
  • Medical University Innsbruck (Austria)
  • University of Bordeaux (France)
  • University of Grenoble (France)
  • Erasmus Medical Center (The Netherlands)
Lead PI Prof. Irene Virgolini, Medical University Innsbruck
Prof. Philippe Fernandez, University of Bordeaux
Dr. Loic Djaileb, University of Grenoble
Prof. Astrid Van Der Velt, Erasmus Medical Center

SPECT Diagnostics

ANNEXIN V-128
99mTc-rhAnnexin V-128 in diagnosis of spondyloarthritis
NCT03232580 AAA II Early diagnosis in spondyloarthritis (SpA) Diagnostic
  • Cedars Sinai Medical Center, Los Angeles, (United States)
Dr Alan D. Waxman, Cedars Sinai Medical Center
ANNEXIN V-128
Study Name/Title 99mTc-rhAnnexin V-128 in diagnosis of spondyloarthritis
Study Number NCT03232580
Sponsor AAA
Phase II
Disease State Early diagnosis in spondyloarthritis (SpA)
Treatment Diagnostic
Center(s)
  • Cedars Sinai Medical Center, Los Angeles, (United States)
Lead PI Dr Alan D. Waxman, Cedars Sinai Medical Center
99mTc-rhAnnexin V-128 imaging for carotid atherosclerosis
NCT02667457 AAA II Carotid atherosclerosis and stroke risk Diagnostic
  • Ottawa Heart Institute, Ottawa Hospital, Ottawa (Canada)
Dr. Terrence Ruddy, Ottawa Hospital
99mTc-rhAnnexin V-128
Study Name/Title 99mTc-rhAnnexin V-128 imaging for carotid atherosclerosis
Study Number NCT02667457
Sponsor AAA
Phase II
Disease State Carotid atherosclerosis and stroke risk
Treatment Diagnostic
Center(s)
  • Ottawa Heart Institute, Ottawa Hospital, Ottawa (Canada)
Lead PI Dr. Terrence Ruddy, Ottawa Hospital
99mTc-rhAnnexin V-128 imaging and cardiotoxicity in patients with early breast cancer
NCT02677714 AAA II Breast cancer Doxorubicin induced cardiomyopathy Diagnostic
  • Ottawa Heart Institute, Ottawa Hospital, Ottawa (Canada)
Dr. Terrence Ruddy, Ottawa Hospital
99mTc-rhAnnexin V-128
Study Name/Title 99mTc-rhAnnexin V-128 imaging and cardiotoxicity in patients with early breast cancer
Study Number NCT02677714
Sponsor AAA
Phase II
Disease State Breast cancer Doxorubicin induced cardiomyopathy
Treatment Diagnostic
Center(s)
  • Ottawa Heart Institute, Ottawa Hospital, Ottawa (Canada)
Lead PI Dr. Terrence Ruddy, Ottawa Hospital
Assessment of 99mTc-rhAnnexin V-128 in infective endocarditis and atrial thrombus
EudraCT N°: 2014-004260-38 INSERM (France) II Diagnosis of infective heart disease Diagnostic
  • Hôpital Bichat, Paris (France)
Prof. Dominique Le Guludec, Hôpital Bichat
99mTc-rhAnnexin V-128
Study Name/Title Assessment of 99mTc-rhAnnexin V-128 in infective endocarditis and atrial thrombus
Study Number EudraCT N°: 2014-004260-38
Sponsor INSERM (France)
Phase II
Disease State Diagnosis of infective heart disease
Treatment Diagnostic
Center(s)
  • Hôpital Bichat, Paris (France)
Lead PI Prof. Dominique Le Guludec, Hôpital Bichat
Imaging of periOP lung injury
NCT02978885 Columbia University (USA) II Detection of perioperative lung injury Diagnostic
  • Columbia University Medical Center, New York (United States)
Dr. Gebhard Wagener, Columbia University
periOP lung injury
Study Name/Title Imaging of periOP lung injury
Study Number NCT02978885
Sponsor Columbia University (USA)
Phase II
Disease State In vivo imaging of destructive processes in COPD
Treatment Diagnostic
Center(s)
  • Columbia University Medical Center, New York (United States)
Lead PI Dr. Gebhard Wagener, Columbia University
Imaging of apoptosis in Chronic Diagnostic Obstructive Pulmonary Disease (COPD)
NCT02978144 Columbia University (USA) II In vivo imaging of destructive processes in COPD Diagnostic
  • Columbia University Medical Center, New York (United States)
Dr. Gebhard Wagener, Columbia University
Chronic Diagnostic Obstructive Pulmonary Disease
Study Name/Title Imaging of apoptosis in Chronic Diagnostic Obstructive Pulmonary Disease (COPD)
Study Number NCT02978144
Sponsor Columbia University (USA)
Phase II
Disease State In vivo imaging of destructive processes in COPD
Treatment Diagnostic
Center(s)
  • Columbia University Medical Center, New York (United States)
Lead PI Dr. Gebhard Wagener, Columbia University
99mTc-rhAnnexin V-128 scintigraphy for the identification of complicated carotid athersclerotic plaques
EudraCT N°: 2017- 002952-99 Assistance Publique - Hopitaux de Paris (France)* II Detection of complicated carotid atherosclerotic plaques Diagnostic
  • Hôpital Bichat, Paris (France)
Prof. Pierre Amarenco, Hôpital Bichat
99mTc-rhAnnexin V-128
Study Name/Title 99mTc-rhAnnexin V-128 scintigraphy for the identification of complicated carotid athersclerotic plaques
Study Number EudraCT N°: 2017- 002952-99
Sponsor Assistance Publique - Hopitaux de Paris (France)*
Phase II
Disease State Detection of complicated carotid atherosclerotic plaques
Treatment Diagnostic
Center(s)
  • Hôpital Bichat, Paris (France)
Lead PI Prof. Pierre Amarenco, Hôpital Bichat
*ANR-16-RHUS-0010_IVASC