Phase 1 Imaging Study of 68Ga-R10602 in Hormone Receptor-Positive Breast Cancer
K
Kathy Miller, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
1
22 participants needed
1 Location
Brief description of study
What is the purpose of this 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.
- Primary: To describe the safety of 68Ga-R10602.
- 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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
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
Email: iutrials@iu.edu
Phone: (317) 278-5632</div>
Detailed description of study
What will happen during the 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)
Updated on
17 Dec 2024.
Study ID: CTO-R10602-101, 24221
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