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

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ClinicalTrials.gov Identifier: NCT03831711
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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. A PET/MRI scan makes computerized images of the inside of the body and uses a radioactive drug to help detect tumors. It is not yet known how well 68-Ga-RM2 works with PET/MRI in imaging patients with estrogen receptor-positive breast cancer.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Estrogen Receptor Positive Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548 Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography Device: Investigational software and coils in PET/MR scan Phase 1 Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer
Estimated Study Start Date : June 18, 2019
Estimated Primary Completion Date : June 18, 2021
Estimated Study Completion Date : June 18, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Arm Intervention/treatment
Experimental: Diagnostic (68-Ga RM2, PET/MRI)
Patients receive 68-Ga RM2 IV and after 45 minutes undergo PET/MRI over 30-60 minutes.
Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
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

Procedure: Magnetic Resonance Imaging
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

Procedure: Positron Emission Tomography
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

Device: Investigational software and coils in PET/MR scan
General Electric (GE) Healthcare non-approved PET scanner coils and software




Primary Outcome Measures :
  1. Detection of ER positive breast cancer and metastases on 68-Ga RM2 PET/MRI [ Time Frame: 24 months ]
    Number of lesions will be 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831711


Contacts
Contact: Shahryar Niknam 408-721-4080 sniknam@stanford.edu

Locations
United States, California
Stanford Cancer Institute Palo Alto Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Shahyar Niknam    408-721-4080    sniknam@stanford.edu   
Principal Investigator: Andrei Iagaru         
Sponsors and Collaborators
Stanford University
General Electric
Investigators
Principal Investigator: Andrei Iagaru Stanford Cancer Institute Palo Alto

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03831711     History of Changes
Other Study ID Numbers: IRB-48150
NCI-2019-00237 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRS0098 ( Other Identifier: OnCore )
IRB-48150 ( Other Identifier: Stanford IRB )
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Bombesin
Gastrin-Releasing Peptide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Gastrointestinal Agents