Clinical trial · Observational
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
NCT02111954CI-TRIAL-00027742completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- F-18-FCH & Ga-68-NODAGA-MJ9
- description
- 1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9
- interventionNames
- Diagnostic Test: 1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9
Primary outcomes (1)
- measure
- Positivity of the new radiotracer Ga-68-NODAGA-MJ9 compared to the standard radiotracer F-18-FCH
- timeFrame
- At baseline (after F-18-FCH PET/CT)
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGnesin 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 30543050