Phase 1 Imaging Study of 68Ga-R10602 in Hormone Receptor-Positive Breast Cancer

Study on Imaging Techniques for Estrogen Receptor-Positive Breast Cancer

K
Kathy Miller, MD

Primary Investigator

Administratively Closed
18 years - 100 years
All
Phase 1
22 participants needed
1 Location

Brief description of study

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.
  1. Primary: To describe the safety of 68Ga-R10602.
  2. Secondary - To describe the biodistribution of 68Ga-R10602 in Study Participants with hormone receptor-positive breast cancer. - To describe organ and whole-body dosimetry of 68Ga-R10602. - To describe the pharmacokinetic (PK) profile of 68Ga-R10602. - To compare 68Ga-R10602 positron emission tomography/computed tomography (PET/CT) scans to standard of care imaging (e.g. contrast-enhanced diagnostic CT images) in detecting tumor lesions in Study Participants with breast cancer. - To describe image quality at simulated lower administered radioactivity of 68Ga-R10602.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Carcinoma, Breast Cancer, Estrogen Receptor Positive
  • Age: 18 years - 100 years
  • Gender: All

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)

This study investigates how well an investigational imaging agent, 68-Ga RM2, works with PET/MRI in patients who have estrogen receptor-positive breast cancer. The purpose is to see how this imaging agent can help visualize cancer in the body. Estrogen receptor-positive breast cancer is a type where cancer cells grow in response to the hormone estrogen.

Participants in this study will receive an intravenous injection of the imaging agent 68-Ga-RM2. After 45 minutes, they will undergo a PET/MRI scan for 30 to 60 minutes. The study will also involve follow-ups at 24 to 72 hours and then for 12 months to monitor the safety and effects of the imaging agent.

  • Who can participate: Adults aged 18 and older with estrogen receptor-positive breast cancer can participate. Key eligibility criteria include being able to provide written consent and having a performance status that allows participation.
  • Study details: Participants will receive an intravenous injection of the imaging agent and undergo a PET/MRI scan. The study will monitor the safety and distribution of the agent in the body.
Updated on 12 May 2026. Study ID: CTO-R10602-101, 24221

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the Study Team