Ga-68-NODAGA-MJ9 Compared to F-18-FCH PET/CT for Prostate Cancer Patients
PET/CT Study of GRP Receptors With Ga-68-NODAGA-MJ9 in Prostate Cancer Compared to F-18-FCH PET / CT
1 other identifier
observational
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
April 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2016
CompletedMay 23, 2017
May 1, 2017
2.6 years
April 9, 2014
May 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
F-18-FCH & Ga-68-NODAGA-MJ9
1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9
Interventions
Each patient will have two PET/CT
Eligibility Criteria
Patient with proven prostate cancer
You may qualify if:
- 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.
You may not qualify if:
- Lack of discernment to sign the consent form
- Age \<18 years
- Patient under hormonal treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011, Switzerland
Related Publications (1)
Gnesin S, Cicone F, Mitsakis P, Van der Gucht A, Baechler S, Miralbell R, Garibotto V, Zilli T, Prior JO. First in-human radiation dosimetry of the gastrin-releasing peptide (GRP) receptor antagonist 68Ga-NODAGA-MJ9. EJNMMI Res. 2018 Dec 12;8(1):108. doi: 10.1186/s13550-018-0462-9.
PMID: 30543050DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John O. Prior, MD, PhD
University of Lausanne Hospitals
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nuclear Medicine Department
Study Record Dates
First Submitted
April 9, 2014
First Posted
April 11, 2014
Study Start
April 1, 2014
Primary Completion
October 28, 2016
Study Completion
October 28, 2016
Last Updated
May 23, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share