Ga-68-NODAGA-MJ9 Compared to F-18-FCH PET/CT for Prostate Cancer Patients

N/ACompletedNCT02111954

University of Lausanne Hospitals60 enrolled

Overview

Prostate cancer patients for whom a F-18-FCH PET/CT is indicated. Ga-68-NODAGA-MJ9 is a new PET/CT radiotracer aiming at giving complementary information : more precise images and early localisation of recurrence to standard imaging

Patient with primary or relapsing prostate cancer for whom F-18-FCH PET/CT is indicated will be proposed to participate to the present study. After signing the patient informed consent, both F-18-FCH and Ga-68-NODAGA-MJ9 PET/CT will be scheduled with a maximum 10 day-interval. No adverse events are expected.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Interventions

1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9DIAGNOSTIC_TEST

Each patient will have two PET/CT

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age : adult patients * Karnofsky : ≥ 80% * Patients with histologically proven prostate cancer for whom 18F-fluocholine PET/CT is indicated for primary cancer staging, or for recurrence with increase of blood PSA. In order to provide a detection probability of 30% or more, a blood PSA 0.5 ng / ml or more in post initial curative intent surgery will be required. * Signed informed consent. Exclusion Criteria: * Lack of discernment to sign the consent form * Age \<18 years * Patient under hormonal treatment

Locations (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Outcomes

Primary Outcomes

Positivity of the new radiotracer Ga-68-NODAGA-MJ9 compared to the standard radiotracer F-18-FCH

PET images : SUVmax, SUVmean, VOI (mL), SUV41% lesions/ SUVbackground CT images : size lesions measured in 3D (axial, coronal and sagittal), density in Hounsfield Units (HU)

Time frame: At baseline (after F-18-FCH PET/CT)

Data from ClinicalTrials.gov

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