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

NCT ID: NCT02111954

Last Updated: 2017-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-10-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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F-18-FCH & Ga-68-NODAGA-MJ9

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

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

Intervention Type DIAGNOSTIC_TEST

Each patient will have two PET/CT

Interventions

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

Each patient will have two PET/CT

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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John O. Prior

Nuclear Medicine Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John O. Prior, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

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Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 30543050 (View on PubMed)

Other Identifiers

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402/12

Identifier Type: -

Identifier Source: org_study_id

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