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CompletedNCT02111954Updated May 23, 2017

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

An observational study in Prostate Cancer, sponsored by University of Lausanne Hospitals. Completed at 1 site in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-23.

Sponsored by University of Lausanne Hospitals · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
Male
01

Study 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

Read the 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.

02

Conditions studied

  • Prostate Cancer

Keywords

  • prostate cancer
  • primary
  • recurrence
  • F-18-FCH PET/CT
  • Ga-68-NODAGA-MJ9 PET/CT
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In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 60 is below the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 119 studies on the registry; 9 are open to participants now.

Browse University of Lausanne Hospitals studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patient with proven prostate cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Lack of discernment to sign the consent form
  • Age \<18 years
  • Patient under hormonal treatment
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • F-18-FCH & Ga-68-NODAGA-MJ9

    1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9

    Diagnostic Test: 1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9

Interventions

  • Diagnostic test1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9

    Each patient will have two PET/CT

    Also known as: 1 PET/CT with F-18-FCH, 1 PET/CT with Ga-68-NODAGA-MJ9

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What researchers measure

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)

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

07

Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, Canton of Vaud 1011, Switzerland
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References and documents

Publications

  • 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. PubMed 30543050 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02111954
Lead sponsor
University of Lausanne Hospitals
Responsible party
John O. Prior (Nuclear Medicine Department, University of Lausanne Hospitals) — Principal investigator
First posted
Apr 11, 2014
Start date
Apr 2014
Primary completion
Oct 28, 2016
Completion
Oct 28, 2016
Last update
May 23, 2017

Study contacts

John O. Prior, MD, PhD
principal investigator · University of Lausanne Hospitals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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