CLINICAL TRIALS

CAAA617A12202 Phase II

Investigator physician : Pr Pierre OLIVIER

Etude visant à évaluer le lutécium (177Lu) vipivotide tétraxétan chez des patients atteints de cancer de la prostate métastatique progressif, résistant à la castration (CPRCm) et présentant une insuffisance rénale modérée ou sévère ou une fonction rénale normale

Patients atteints de cancer de la prostate métastatique, progressif, résistant à la castration, positif pour l’antigène membranaire spécifique de la prostate (PSMA pour prostate-specific membrane antigen), et présentant une :
- Insuffisance rénale modérée
-Insuffisance rénale sévère
- Fonction rénale normale

Traitement : 177Lu-PSMA-617
Study status: En cours d'inclusion

CAPRI Phase III

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 au 18F-Florebetaben
Study status: Recruiting
Funding: PHRC Nationale French Ministry of Health

DATTEP Phase III

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 et Tremblement Essentiel

Imaging: PET/CT 18F-LBT-999 (produit à l'étude) versus [123I]-FP-CIT en SPECT/CT
Study status: Terminated

DEBIO 1228-101 PART A Phase I

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
Study status: Recruiting

DEBIO 1228-101 PART A Phase I

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

Thérapy : [177Lu]Lu-DPI-4452
Study status: Recruiting

DORA

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

Gliioma

The treatment under study: Diagnostic PET/CT à la 18F-FDOPA
Study status: Recruiting
Funding: Clinical Research Program Contract of Nancy Hospital

DOTAMIR Phase III

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
Study status: Terminated
Funding: French East Organization funding

DOTENDO Phase II

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 au 18F-Florebetaben
Study status: Terminated
Funding: Clinical Research Program Contract of Nancy Hospital

EAGLE-i Phase III

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

Les patients chez qui un cancer de la prostate a été récemment diagnostiqué et pour lesquels il est initialement prévu d'effectuer une chirurgie d'ablation de la prostate et des ganglions lymphatiques pelviens (prostatectomie radicale avec dissection élargie des ganglions lymphatiques pelviens (RP avec EPLND)

Imagerie: TEP/TDM 18FPSMA-1007
Study status: Recruiting

Coordinating center

ECLIPSE Phase III

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
Study status: Recruiting

ELUMEN Phase IIb

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®
Study status: Not yet recruiting
Funding: InCA

EVADOVE 177Lu

Investigator physician : Dr Elodie CHEVALIER

Evaluation d’une méthode de dosimétrie en routine clinique en caméra VERITON-CT™ chez des patients traités par Lutathera [177Lu- [DOTA0, Tyr3] -octréotate

Patients receiving Luthatera ® therapy

The treatment under study: Dosimétrie en VERITON-CT ™
Study status: Terminated
Funding: Not applicable

FILM

Investigator physician : Dr Marine CLAUDIN

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

Crohn's disease

The treatment under study: Dagnostic PET/CT au 18F-FDG
Study status: Recruiting
Funding: Regional - French Ministry of Health

GATEDOTA

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
Study status: Recruiting
Funding: Not applicable

HYDEM

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
Study status: Recruiting
Funding: French East Organization funding

KING Phase IIIb

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: TEP/TDM au 18F-FDOPA
Study status: Recruiting
Funding: PHRC-K InCA

MIBI Thyr

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: SPECT/CT en 123Iode
Study status: Recruiting

MUSIC

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
Study status: Recruiting
Funding: French East Organization funding

PERQUAL

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
Study status: Recruiting
Funding: Not applicable

PROACTIF - BTG 007996-01 Phase IV / Registre

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)
Study status: Recruiting

PSMA Addition Phase III

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
Study status: Closed Follow-up of patients

ReLUTH Phase II

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 ®
Study status: Recruiting

SATISFACTION Phase I/II

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)

Thérapy: 225Ac-PSMA-R2
Study status: Recruiting

TEP-COV

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 au 18F-FDG
Study status: Terminated
Funding: Not applicable

VERICATH Clinical investigation according to RE 2017/745

Investigator physician : Dr Elodie CHEVALIER

Évaluation d’une procédure d’enregistrement corps entier 3D en caméra CZT « VERITON-CT™ » : Comparaison à la procédure classique d’enregistrement 2D corps entier associée à des tomoscintigraphies complémentaires chez des patients ayant reçu un traitement par Iode 131 pour un Cancer Thyroïdien

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

The treatment under study: VERITON-CT™ camera
Study status: Recruiting
Funding: Not applicable