Clinical trial

A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy

Name

IRB-48213

Description

This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.

Trial arms

Trial start

2019-04-09

Estimated PCD

2022-03-07

Trial end

2022-03-07

Status

Completed

Phase

Early phase I

Treatment

68-Ga RM2

Radioactive agent

Arms:

68-Ga PSMA11+68-Ga RM2, 68-Ga RM2+68-Ga PSMA11

Other names:

68Ga-DOTA-4-amino-1-carboxymethyl-piperidine-DPhe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, 68Ga-DOTA-Bombesin, BAY86-7548

68-Ga PSMA11

Radioactive agent

Arms:

68-Ga PSMA11+68-Ga RM2, 68-Ga RM2+68-Ga PSMA11

Other names:

DFKZ 11, HBED CC PSMA, Heidelberg compound

Investigational software and coils in PET/MR Scan

Investigational software and coils in PET/MR Scan by General Electric Healthcare

Arms:

68-Ga PSMA11+68-Ga RM2, 68-Ga RM2+68-Ga PSMA11

PET/MRI

Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan

Arms:

68-Ga PSMA11+68-Ga RM2, 68-Ga RM2+68-Ga PSMA11

Other names:

Positron emission tomography (PET)/Magnetic resonance imaging (MRI)

Size

Primary endpoint

Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained

Up to approximately 2 hours to complete each scan

Eligibility criteria

Inclusion Criteria: * Known prostate cancer * Planned HIFU or HDR local therapy * Able to provide written consent * Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}

Updated at

2024-01-30

1 organization

2 products

1 indication

Organization

Product

Indication

Product