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Completed

NCT Number: NCT03831711

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

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Estrogen Receptor Positive Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

Drug

Given IV

Other names: (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

Procedure

Undergo PET/MRI

Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Positron Emission Tomography

Procedure

Undergo PET/MRI

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Investigational software and coils in PET/MR Scan

Device

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

Primary outcomes

  1. Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI

    Time frame: up to 2 hours

    Number of lesions identified on 68-Ga RM2 positron emission tomography/magnetic resonance imaging (PET/MRI). The outcome will be reported as the number of participants with successful PET based detection of estrogen receptor (ER) positive breast cancer and metastases.

Sponsors and collaborators

Lead sponsor

Andrei Iagaru

Other

Collaborators

  • General Electric

Registry information

Official study title

A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2019
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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