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

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: 1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9

• Registration Number: NCT02111954
• Lead Sponsor: University of Lausanne Hospitals

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Primary Completion: 2016-10-28
• Study Completion: 2016-10-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-20
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
F-18-FCH & Ga-68-NODAGA-MJ9	1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9	1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9

Primary Outcome Measures

Name	Time	Method
Positivity of the new radiotracer Ga-68-NODAGA-MJ9 compared to the standard radiotracer F-18-FCH	At baseline (after F-18-FCH PET/CT)	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)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland