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68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

NCT03809078 — Phase 2, Completed, 14 participants, Andrei Iagaru
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A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

RegistryNCT03809078
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, sequential, masking: none, diagnostic
Enrollment14 (Actual)
SponsorAndrei Iagaru (Other); collaborators: General Electric
ConditionsProstate Cancer
Interventions68Ga RM2, 68Ga-PSMA-11, Investigational PET scanner coils and software (Drug, device)
Datesstart 2019-01-14, primary completion 2022-03-08, completion 2022-03-08, first posted 2019-01-18, last updated 2024-01-11
Locations1 site in United States

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-Summary

The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

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+Detailed description

Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Exploratory Objective:

* Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy
* Correlation of 68Ga RM2 and Gleason score at biopsy

+Arms and interventions

ArmTypeInterventionsDescription
68Ga RM2 first followed by 68Ga PSMA11ExperimentalDrug: 68Ga RM2; Drug: 68Ga-PSMA-11; Device: Investigational PET scanner coils and softwareParticipant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
68Ga PSMA11 first followed by 68Ga RM2ExperimentalDrug: 68Ga RM2; Drug: 68Ga-PSMA-11; Device: Investigational PET scanner coils and softwareParticipant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
  • 68Ga RM2 (Drug), also known as 68Ga DOTA Bombesin, BAY86 7548: PET radiopharmaceutical
  • 68Ga-PSMA-11 (Drug), also known as DFKZ 11, HBED CC PSMA, Heidelberg compound: PET radiopharmaceutical
  • Investigational PET scanner coils and software (Device): GE Healthcare non-approved PET scanner coils and software

+Outcome measures

Primary outcomes

  • Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings [Up to approximately 2 hours to complete each scan]: Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Suspected prostate cancer
* Planned prostate biopsy
* Able to provide written consent
* Karnofsky performance status of 50 (or ECOG/WHO equivalent)

Exclusion Criteria:

* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
* Metallic implants (contraindicated for MRI)

+Posted results

Participant flow

Milestone68Ga PSMA11 First Followed by 68Ga RM268Ga RM2 First Followed by 68Ga PSMA11
Started77
Completed77
Not completed00

Outcome results

  • Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings (Primary), Count of participants, Participants: 68Ga PSMA11 13; 68Ga RM2 13

Adverse events

Time frame: 2 weeks, plus safety follow up at to 72 hours after the final scan

ArmDeathsSerious adverse eventsOther adverse events
68Ga PSMA110/14 (0.0%)0/14 (0.0%)0/14 (0.0%)
68Ga RM20/13 (0.0%)0/13 (0.0%)0/13 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Stanford UniversityStanford, CaliforniaUnited States

+Publications

  • Results publication: Duan H, Ghanouni P, Daniel B, Rosenberg J, Thong A, Kunder C, Aparici CM, Davidzon GA, Moradi F, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Biopsy Guidance in Patients with Suspected Prostate Cancer. J Nucl Med. 2023 May;64(5):744-750. doi: 10.2967/jnumed.122.264448. Epub 2022 Nov 17. PMID 36396456

+Study documents

+Investigators

My Notes