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 Indication Treatment Center(s) Lead PI

177Lutetium Dotatate (Therapeutic)

177Lutetium Dotatate
Netter-1: Study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive midgut carcinoid tumours NCT01578239 AAA III Inoperable, progressive, somatostatin receptor positive midgut carcinoid tumours 177Lutetium Dotatate vs Octreotide LAR
  • 14 US sites
  • 27 European sites (Belgium, France, Germany, Italy, Portugal, Spain, UK)
NA
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 tumours
Study Number NCT01578239
Sponsor AAA
Phase III
Indication Inoperable, progressive, somatostatin receptor positive midgut carcinoid tumours
Treatment 177Lutetium Dotatate vs Octreotide LAR
Center(s)
  • 14 US sites
  • 27 European sites (Belgium, France, Germany, Italy, Portugal, Spain, UK)
Lead PI NA
OCLURANDOM: Antitumor efficacy of PRRT with 177Lutetium Octreotate randomized vs Sunitinib in unresectable progressive well-differentiated neuroendocrine pancreatic carcinoma NCT02230176 Gustave Roussy Institute (France) II Progressive unresectable pNETs 177Lutetium 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)
Dr. 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 carcinoma
Study Number NCT02230176
Sponsor Gustave Roussy Institute (France)
Phase II
Indication Progressive unresectable pNETs
Treatment 177Lutetium 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 Dr. Eric Baudin, Gustave Roussy Institute
LuDo: A phase IIa trial of 177Lutetium 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 177Lutetium Dotatate 75 MBq/kg with adjustment from 50 to 100 MBq/Kg
  • University College London Hospitals (UK)
Dr. Mark Gaze, University College London Hospitals
LuDo
Study Name/Title LuDo: A phase IIa trial of 177Lutetium 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
Indication Primary refractory or relapsed high risk neuroblastoma
Treatment 177Lutetium Dotatate 75 MBq/kg with adjustment from 50 to 100 MBq/Kg
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 177Lutetium Dotatate vs Lu+Capecitabine
  • IRST, Meldola (Italy)
Dr. 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
Indication FDG positive GEP-NET tumors
Treatment 177Lutetium Dotatate vs Lu+Capecitabine
Center(s)
  • IRST, Meldola (Italy)
Lead PI Dr. Giovanni Paganelli, IRST
LUNET: PRRT with radiolabelled somatostatin analogue 177Lu Dotatate in advanced GEP-NET, FDG-PET negative patients NCT02489604 IRST Meldola (Italy) II Advanced GEP-NETs (FDG neg) 177Lutetium Dotatate (5x and 7x100mCi)
  • IRST, Meldola (Italy)
Dr. Maddalena Sansovini, IRST
LUNET
Study Name/Title LUNET: PRRT with radiolabelled somatostatin analogue 177Lu Dotatate in advanced GEP-NET, FDG-PET negative patients
Study Number NCT02489604
Sponsor IRST Meldola (Italy)
Phase II
Indication Advanced GEP-NETs (FDG neg)
Treatment 177Lutetium Dotatate (5x and 7x100mCi)
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 177Lu Dotatate EudraCT N°: 2015-004727-31 IRST Meldola (Italy) II SSTR2 positive tumors patients 177Lutetium Dotatate 3.7 GBq x 5 admin vs 5.5 GBq x 5 admin.
  • 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 177Lu Dotatate
Study Number EudraCT N°: 2015-004727-31
Sponsor IRST Meldola (Italy)
Phase II
Indication SSTR2 positive tumors patients
Treatment 177Lutetium Dotatate 3.7 GBq x 5 admin vs 5.5 GBq x 5 admin.
Center(s)
  • IRST, Meldola (Italy)
Lead PI Dr. Stefano Severi, IRST
PREELU: Prediction of radio-exposure induced by patients treated by 177Lutetium Dotatate NA Association Robert Debré (France) NA Radiation exposure following Temporary Authorization of Use in midgut NETs 177Lutetium 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 177Lutetium Dotatate
Study Number NA
Sponsor Association Robert Debré (France)
Phase NA
Indication Radiation exposure following Temporary Authorization of Use in midgut NETs
Treatment 177Lutetium Dotatate
Center(s)
  • Hôpital Saint Antoine - APHP (France)
Lead PI Dr. Jules Zhang-Yin, Hôpital Saint Antoine - APHP

SomaKit TOC (Ga 68 PET Diagnostic)

SomaKit TOC™
Safety and tolerability study of Ga 68 Dotatoc in patients with proven gastro-entero-pancreatic tumours (GEP-NETs) EudraCT N°: 2014-002741-21 AAA I/IIa Diagnosis for the management of GEP-NETs Diagnostic
  • The Christie NHS Foundation Trust (UK)
  • The Royal Free Hospital NHS Foundation Trust (UK)
Dr. Prakash Manoharan, Christie NHS Foundation Dr. Shaunak Navalkissoor, Royal Free Hospital
Ga 68 Dotatoc
Study Name/Title Safety and tolerability study of Ga 68 Dotatoc in patients with proven gastro-entero-pancreatic tumours (GEP-NETs)
Study Number EudraCT N°: 2014-002741-21
Sponsor AAA
Phase I/IIa
Indication Diagnosis for the management of GEP-NETs
Treatment Diagnostic
Center(s)
  • The Christie NHS Foundation Trust (UK)
  • The Royal Free Hospital NHS Foundation Trust (UK)
Lead PI Dr. Prakash Manoharan, Christie NHS Foundation Dr. Shaunak Navalkissoor, Royal Free Hospital
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 I/IIa Advanced TKI-treated GIST Diagnostic
  • Medical University Innsbruck
Dr. Irene Virgolini, Medical University Innsbruck
MITIGATE
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
Phase I/IIa
Indication Advanced TKI-treated GIST
Treatment Diagnostic
Center(s)
  • Medical University Innsbruck
Lead PI Dr. Irene Virgolini, Medical University Innsbruck

F-18 FES (F-18 PET Diagnostic)

F-18 FES
ET-FES STUDY 174-01 for early prediction of efficacy of endocrine therapy in breast cancer: pilot study and validation with 18F Fluoroestradiol (FES) PET/CT EudraCT N°: 2013-000287-29 Ente Ospedaliero Ospedali Galliera II Patients with histologically or cytologically confirmed endocrine receptor-positive Metastatic Breast Cancer at first evidence of metastatic disease Diagnostic
  • E. O. Ospedali Galliera (Italy)
  • IRCCS-IRST, Meldola (FC) (Italy)
  • University of Munich/ Klinikum Grosshadern (Germany)
  • Hôpital René Huguenin/Institut Curie (France)
  • Vall d’Hebron University Hospital (Spain)
  • European Institute of Oncology (Italy)
  • IRCC Candiolo (Italy)
  • A.O. Sant’Anna – Ferrara (Italy)
Dr. Alessandra Gennari, E. O. Ospedali Galliera
ET-FES STUDY 174-01
Study Name/Title ET-FES STUDY 174-01 for early prediction of efficacy of endocrine therapy in breast cancer: pilot study and validation with 18F Fluoroestradiol (FES) PET/CT
Study Number EudraCT N°: 2013-000287-29
Sponsor Ente Ospedaliero Ospedali Galliera
Phase II
Indication Patients with histologically or cytologically confirmed endocrine receptor-positive Metastatic Breast Cancer at first evidence of metastatic disease
Treatment Diagnostic
Center(s)
  • E. O. Ospedali Galliera (Italy)
  • IRCCS-IRST, Meldola (FC) (Italy)
  • University of Munich/ Klinikum Grosshadern (Germany)
  • Hôpital René Huguenin/Institut Curie (France)
  • Vall d’Hebron University Hospital (Spain)
  • European Institute of Oncology (Italy)
  • IRCC Candiolo (Italy)
  • A.O. Sant’Anna – Ferrara (Italy)
Lead PI Dr. Alessandra Gennari, E. O. Ospedali Galliera

Annexin V-128 (SPECT Diagnostic)

Annexin V-128
99mTc-rhAnnexin V-128 a Phase I/IIa study in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS) NCT02328027 AAA I/II Rheumatoid arthritis and ankylosing spondylitis patients Diagnostic
  • Centre Hospitalier Universitaire Vaudois, Lausanne (Switzerland)
Dr. John Prior, Centre Hospitalier Universitaire Vaudois
99mTc-rhAnnexin V-128
Study Name/Title 99mTc-rhAnnexin V-128 a Phase I/IIa study in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS)
Study Number NCT02328027
Sponsor AAA
Phase I/II
Indication Rheumatoid arthritis and ankylosing spondylitis patients
Treatment Diagnostic
Center(s)
  • Centre Hospitalier Universitaire Vaudois, Lausanne (Switzerland)
Lead PI Dr. John Prior, Centre Hospitalier Universitaire Vaudois
99mTc-rhAnnexin V-128 imaging for carotid atherosclerosis NCT02667457 AAA II Carotid atherosclerosis and risk for stroke 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
Indication Carotid atherosclerosis and risk for stroke
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 Assessment of risk for cardio toxicity 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
Indication Assessment of risk for cardio toxicity
Treatment Diagnostic
Center(s)
  • Ottawa Heart Institute, Ottawa Hospital, Ottawa (Canada)
Lead PI Dr. Terrence Ruddy,
Ottawa Hospital
99mTc-rhAnnexin V-128 for detection of infective endocarditis and atrial thrombus EudraCT N°: 2014-004260-38 INSERM (France) II Diagnosis of infective heart disease Diagnostic
  • Hôpital Bichat, Paris (France)
Dr. Dominique Le Guludec, Hôpital Bichat
99mTc-rhAnnexin V-128
Study Name/Title 99mTc-rhAnnexin V-128 for detection of infective endocarditis and atrial thrombus
Study Number EudraCT N°: 2014-004260-38
Sponsor INSERM (France)
Phase II
Indication Diagnosis of infective heart disease
Treatment Diagnostic
Center(s)
  • Hôpital Bichat, Paris (France)
Lead PI Dr. Dominique Le Guludec, Hôpital Bichat