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68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer

NCT ID: NCT03831711

Last Updated: 2023-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-19

Study Completion Date

2021-11-15

Brief Summary

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This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen receptor-positive breast cancer. 68-Ga-RM2 is an agent used in diagnostic imaging.

Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate the feasibility of 68-Ga RM2 PET/MRI for identification of estrogen receptor positive primary breast cancer and metastases

OUTLINE:

Patients receive 68-Ga-RM2 intravenously (IV) and after 45 minutes undergo PET/MRI over 30-60 minutes.

After completion of study, patients are followed up at 24-72 hours, and then for 12 months.

Conditions

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Breast Carcinoma Estrogen Receptor Positive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (68-Ga RM2, PET/MRI)

Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.

Group Type EXPERIMENTAL

Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

Intervention Type DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo PET/MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/MRI

Investigational software and coils in PET/MR scan

Intervention Type DEVICE

General Electric (GE) Healthcare non-approved PET scanner coils and software

Interventions

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Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

Given IV

Intervention Type DRUG

Magnetic Resonance Imaging

Undergo PET/MRI

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET/MRI

Intervention Type PROCEDURE

Investigational software and coils in PET/MR scan

General Electric (GE) Healthcare non-approved PET scanner coils and software

Intervention Type DEVICE

Other Intervention Names

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(68)-Ga-DOTA-4-amino-1-carboxymethylpiperidine-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2 68-Ga-Bombesin Antagonist BAY86-7548 68-Ga-DOTA RM2 68-Ga-DOTA-Bombesin Analog BAY86-7548 [68-Ga]-labeled Bombesin Analog BAY86-7548 [68-Ga]RM2 BAY 86-7548 Ga-68-labeled Bombesin Antagonist BAY 86-7548 Gallium Ga-68-labeled GRPR Antagonist RM2 Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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Inclusion Criteria

* ER+ breast cancer at initial diagnosis prior to surgery or at recurrence (at least one ER+ lesion based on results of biopsy).
* Able to provide written consent
* Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent)

Exclusion Criteria

* Less than 18 years-old at the time of radiotracer administration
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
* Renal function impairment preventing administration of MRI contrast
* Metallic implants (contraindicated for MRI)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Electric

INDUSTRY

Sponsor Role collaborator

Andrei Iagaru

OTHER

Sponsor Role lead

Responsible Party

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Andrei Iagaru

Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrei Iagaru

Role: PRINCIPAL_INVESTIGATOR

Stanford Cancer Institute Palo Alto

Locations

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Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCI-2019-00237

Identifier Type: REGISTRY

Identifier Source: secondary_id

BRS0098

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-48150

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-48150

Identifier Type: -

Identifier Source: org_study_id