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Trial record 1 of 1 for:    NCT02111954
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Ga-68-NODAGA-MJ9 Compared to F-18-FCH PET/CT for Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT02111954
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
John O. Prior, 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

Condition or disease Intervention/treatment
Prostate Cancer Diagnostic Test: 1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9

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.


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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PET/CT Study of GRP Receptors With Ga-68-NODAGA-MJ9 in Prostate Cancer Compared to F-18-FCH PET / CT
Study Start Date : April 2014
Actual Primary Completion Date : October 28, 2016
Actual Study Completion Date : October 28, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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
Each patient will have two PET/CT
Other Names:
  • 1 PET/CT with F-18-FCH
  • 1 PET/CT with Ga-68-NODAGA-MJ9




Primary Outcome Measures :
  1. Positivity of the new radiotracer Ga-68-NODAGA-MJ9 compared to the standard radiotracer F-18-FCH [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with proven prostate cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111954


Locations
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Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
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Principal Investigator: John O. Prior, MD, PhD University of Lausanne Hospitals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John O. Prior, Nuclear Medicine Department, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02111954     History of Changes
Other Study ID Numbers: 402/12
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John O. Prior, University of Lausanne Hospitals:
prostate cancer
primary
recurrence
F-18-FCH PET/CT
Ga-68-NODAGA-MJ9 PET/CT

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases