CLINICAL TRIALS

CAAA617A12202

Study status: Recruiting

Investigator physician : Pr Pierre OLIVIER

Study evaluating lutetium (177Lu) vipivotide tetraxetan in patients with progressive metastatic castration-resistant prostate cancer (mCRPC) with moderate or severe renal impairment or normal renal function

Patients with progressive metastatic castration-resistant prostate cancer, positive for prostate-specific membrane antigen (PSMA), with:
- Moderate renal impairment
- Severe renal impairment
- Normal renal function

Treatment: 177Lu-PSMA-617
Phase II

ACTION-01

Study status: Recruiting

Investigator physician : Dr Caroline BOURSIER

Phase 1b/3 randomized, controlled, open-label trial comparing RYZ101 with standard treatment in patients with inoperable, advanced, well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NET) expressing somatostatin receptors (SSTR+) that progressed after prior treatment with a 177Lu-labeled somatostatin analogue (177Lu-SSA)

Gastroenteropancreatic neuroendocrine tumors (GEP-NET)

Treatment: RYZ101 (225Ac-DOTATATE)
Phase 1b/III

CAPRI

Study status: Terminated

Investigator physician : Pr Pierre-Yves MARIE

Assessment of the 18F-florbetaben whole-body PET imaging diagnostic performance for the detection of cardiac and extracardiac sites of amyloid deposits in patients with amyloidosis

Amyloidosis

The treatment under study: Diagnostic PET/CT with 18F-Florebetaben
Phase III

DATTEP

Study status: Terminated

Investigator physician : Dr Lucie HOPES

Non-inferiority Study of the Molecular Imaging of Dopamine Transporters Using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to Distinguish Between Parkinson's Disease and Essential Tremor

Parkinson's disease and essential tremor

Imaging: PET/CT 18F-LBT-999 (investigational product) versus [123I]-FP-CIT SPECT/CT
Phase III

DEBIO 1228-101 PART A

Study status: Terminated

Investigator physician : Pr Pierre OLIVIER

A multicenter, open-label, non-randomized Phase 1/2 study to assess safety,tolerability, and imaging characteristics of [68Ga]Ga-DPI-4452 and to assess safety, tolerability, and efficacy of [177Lu]Lu-DPI-4452 in patients with unresectable locally advanced or metastatic solid tumors

Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:
- ccRCC: patients must have received at least one line containing TKI treatment and at least one line containing Immune Checkpoint Inhibitor treatment in metastatic setting, meaning at least two lines of treatment in metastatic setting; or
- PDAC: patients must have received at least one line of platinum- and/or gemcitabine-based regimen; or
- CRC: patients must have received at least one line of FOLFIRINOX or FOLFOX/FOLFIRI in two lines in combination with anti-VEGF or anti-EGFR

Diagnostic: [68Ga]Ga-DPI-4452
Phase I

DEBIO 1228-101 PART B & C

Study status: Recruiting

Investigator physician : Pr Pierre OLIVIER

A multicenter, open-label, non-randomized Phase 1/2 study to assess safety,tolerability, and imaging characteristics of [68Ga]Ga-DPI-4452 and to assess safety, tolerability, and efficacy of [177Lu]Lu-DPI-4452 in patients with unresectable locally advanced or metastatic solid tumors

Histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:
- ccRCC: patients must have received at least one line containing TKI treatment and at least one line containing Immune Checkpoint Inhibitor treatment in metastatic setting, meaning at least two lines of treatment in metastatic setting; or
- PDAC: patients must have received at least one line of platinum- and/or gemcitabine-based regimen; or
- CRC: patients must have received at least one line of FOLFIRINOX or FOLFOX/FOLFIRI in two lines in combination with anti-VEGF or anti-EGFR

Therapy: [177Lu]Lu-DPI-4452
Phase I

DORA

Study status: Terminated

Investigator physician : Pr Antoine VERGER

Contribution of Cerebral 18F-DOPA PET-CT Scan in High-grade Recurrent Gliomas : a Monocentric Pilot Impact Study on the Practices of Defining Target Volumes Before RAdiotherapy

Glioma

The treatment under study: Diagnostic PET/CT with 18F-FDOPA

DOTAMIR

Study status: Terminated

Investigator physician : Dr Elodie CHEVALIER

Pilot study evaluating somatostatin receptor PET imaging to detect inflammatory phases of myocarditis

Myocarditis

The treatment under study: Diagnostic PET/CT 68Ga-DOTATOC
Phase III

DOTENDO

Study status: Terminated

Investigator physician : Dr Caroline BOURSIER

Early feasibility study of somatostatin receptor PET imaging for the diagnosis of infective endocarditis

Infective endocarditis

The treatment under study: Diagnostic PET/CT with 18F-Florebetaben
Phase II

EAGLE-i

Study status: Recruiting

Investigator physician : Pr Pierre OLIVIER

Prospective multicenter study to evaluate the diagnostic performance of [18F]PSMA-1007 PET/CT imaging in patients with newly diagnosed high-risk or very high-risk prostate cancer

Patients with newly diagnosed prostate cancer for whom surgical removal of the prostate and pelvic lymph nodes is initially planned (radical prostatectomy with extended pelvic lymph node dissection [RP with EPLND])

Imaging: [18F]PSMA-1007 PET/CT
Phase III

Coordinating center

ECLIPSE

Study status: Closed follow-up of patients

Investigator physician : Pr Pierre OLIVIER

A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer

Metastatic Castration-Resistant Prostate Cancer

The treatment under study: 177Lu-PSMA-I&T
Phase III

ELUMEN

Study status: Recruiting

Investigator physician : Pr Antoine VERGER

Evaluation of the addition of Everolimus to 177Lu-DOTATATE in the treatment of grades 2 and 3 refractory meningioma: a phase IIb clinical trial

Grade 2 and 3 refractory meningioma

Therapy: Everolimus®
Phase IIb

EVADOVE 177Lu

Study status: Terminated

Investigator physician : Dr Elodie CHEVALIER

Evaluation of a routine clinical dosimetry method using the VERITON-CT™ camera in patients treated with Lutathera [177Lu-[DOTA0, Tyr3]-octreotate

Patients receiving Luthatera ® therapy

The treatment under study: VERITON-CT™ dosimetry

FILM

Study status: Recruiting

Investigator physician : Dr Marine CLAUDIN

Optimized Imaging of Fibrosis and Intestinal Inflammation in Crohn's Disease

Crohn's disease

The treatment under study: Diagnostic PET/CT with 18F-FDG

GATEDOTA

Study status: Recruiting

Investigator physician : Dr Mathieu PERRIN

GATED cardiac analysis in patients with 68GA-DOTATOC PET for oncological indications

Diagnostic or pre-therapeutic workup or follow-up of a neuroendocrine tumor

The treatment under study: Diagnostic PET/CT 68Ga-DOTATOC

HEFITEP

Study status: Recruiting

Investigator physician : Dr Elodie CHEVALIER

Pilot study to evaluate the stage of liver fibrosis using PET imaging of fibroblast activation protein (68Ga-FAPI-46 PET/CT) in patients who have undergone biopsy for suspected or confirmed non-alcoholic steatohepatitis (NASH)

Metabolic dysfunction-associated Steatotic Liver Disease

Diagnostic: 68Ga-FAPI-46
Phase II

HYDEM

Study status: Recruiting

Investigator physician : Martine Louis

Randomized controlled trial evaluating the efficacy of HYpnosis using a DEported method adapted to Nuclear Medicine versus hypnosis using a conventional method

Ericksonian hypnosis session given to patients during a scintigraphic or PET examination in a remote setting

The treatment under study: Paramedical

KING

Study status: Recruitment completed, analyses in progress

Investigator physician : Pr Antoine VERGER

Evaluation of diagnostic performances of 18F-FDOPA PET KInetics as biomarkers for the improvement of care of MRI Non-contrast enhanced Gliomas

Suspicion of Glioma with MRI non contrast enhanced

Diagnostic: 18F-FDOPA PET/CT
Phase IIIb

MIBI Thyr

Study status: Recruiting

Investigator physician : Pr Laurent BRUNEAU

Interest of the combination of ultrasound with Ti-RADS score / dual tracer MIBI-Tc99m/Iodine-123 scintigraphy in the detection of malignancy of thyroid nodules (≥ 15 mm) classified Bethesda III or IV in cytopuncture

Thyroid nodules (≥ 15 mm) classified as Bethesda III or IV on cytopuncture

Imaging: Iodine-123 SPECT/CT

MUSIC

Study status: Recruiting

Investigator physician : Dr Achraf BAHLOUL

Contribution of MUltiparametric analysis in bone scintigraphy for the characterization of solitary bone lesions whose malignant origin cannot be excluded on conventional imaging

Patients with solitary bone lesions indeterminate on conventional imaging who are scheduled for biopsy or excision

Diagnostic: SPECT-CT

PEACE 6

Study status: Recruiting

Investigator physician : Dr Marine CLAUDIN

Randomized phase III trial aiming to evaluate whether administration of 177Lu-PSMA-617 could improve disease management in men with de novo metastatic hormone-sensitive prostate cancer who are poor responders to standard treatment

Patients with de novo metastatic hormone-sensitive prostate cancer with serum PSA ≥ 0.2 ng/mL, 6 to 8 months after initiation of systemic therapy for mHSPC (i.e., with an unsatisfactory response to systemic therapy) in the absence of evidence of disease progression (including rising PSA)

Treatment: 177Lu-PSMA-617
Phase III

PERQUAL

Study status: Recruiting

Investigator physician : Dr Achraf BAHLOUL

Diagnostic performance of SPECT/CT bone scan quantification prior to lumbar arthodesis surgery

People with back pain for at least 3 months (presumed to be due to degenerative discarthrosis or spondylolisthesis)

The treatment under study: SPECT/CT bone scan quantification

PROACTIF - BTG 007996-01

Study status: Recruiting

Investigator physician : Dr Elodie CHEVALIER

A prospective, post-authorization, multicenter, open-label, non-interventional registry study to evaluate the efficacy of TheraSphere® in clinical practice in France

Unresectable hepatocellular carcinoma (HCC)

Treatment: TheraSphere, Yttrium-90 glass microspheres (routine care)
Phase IV / Registre

PSMA Addition

Study status: Closed Follow-up of patients

Investigator physician : Pr Pierre OLIVIER

An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

The treatment under study: 177Lu-PSMA-617
Phase III

ReLUTH

Study status: Recruiting

Investigator physician : Dr Elodie CHEVALIER

A prospective randomized phase ii study to assess the schemas of retreatment with lutathera® ([177Lu]lu-dota-tate) in patients with new progression of intestinal well-differentiated neuroendocrine tumor

intestinal well-differentiated neuroendocrine tumor

Treatment: Lutathera ®
Phase II

SATISFACTION

Study status: Recruiting

Investigator physician : Pr Pierre OLIVIER

A Phase I/II, open-label, multi-center study of [225Ac]Ac-PSMA-R2 in men with heavily pre-treated PSMA positive metastatic castration resistant prostate cancer (mCRPC) with or without prior 177Lu-labelled PSMAtargeted radioligand therapy

pre-treated PSMA positive metastatic castration resistant prostate cancer (mCRPC)

Therapy: 225Ac-PSMA-R2
Phase I/II

TEP-COV

Study status: Terminated

Investigator physician : Pr Antoine VERGER

18F-FDG PET/CT characterization of brain lesions in young subjects with sequelae of psycho-cognitive disorders in the aftermath of severe Covid-19

Sequelae of psycho-cognitive disorders following severe Covid-19

The treatment under study: Diagnostic PET/CT with 18F-FDG

VERICATH

Study status: Terminated

Investigator physician : Dr Elodie CHEVALIER

Evaluation of a 3D whole-body acquisition procedure using the CZT VERITON-CT™ camera: comparison with the standard 2D whole-body acquisition procedure combined with additional SPECT imaging in patients treated with iodine-131 for thyroid cancer

Thyroid cancer patients for whom multidisciplinary consultation meeting has validated iratherapy treatment

The treatment under study: VERITON-CT™ camera
Clinical investigation according to RE 2017/745

LUMIERE

Study status: Recruiting

Investigator physician : Dr Boursier Caroline

A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry,and Preliminary Activity of [177Lu]Lu-FAP-2286 in Participants with an Advanced Solid Tumor

Solid tumors

Imaging: [68Ga]Ga-FAP-2286
Therapeutic agent: [177Lu]Lu-FAP-2286
Phase I/II

GCJ904

Study status: Recruiting

Investigator physician : Dr Caroline Boursier

A phase I open-label, multi-center study to evaluate the safety, tolerability, dosimetry, and preliminary activity of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients with solid tumors

Solid tumors:
- Locally advanced or metastatic PDAC,
- NSCLC,
- HR+/HER2- ductal and lobular breast cancer,
- Triple-negative breast cancer,
- CRC and soft tissue sarcoma

[68Ga]Ga-NNS309
[177Lu]Lu-DFC413
Phase I

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