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

Prostate Cancer Clinical Trial

Official title:

PET/CT Study of GRP Receptors With Ga-68-NODAGA-MJ9 in Prostate Cancer Compared to F-18-FCH PET / CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111954
• Other study ID #: 402/12
• Status: Completed
• Phase: N/A
• First received: April 9, 2014
• Last updated: May 20, 2017
• Start date: April 2014
• Est. completion date: October 28, 2016

Study information

• Verified date: May 2017
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 28, 2016
• Est. primary completion date: October 28, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9
Each patient will have two PET/CT

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At baseline (after F-18-FCH PET/CT)