RECRUITING

Study of 68Ga-R10602

Conditions

Locoregionally Recurrent Hormone-receptor Positive Breast Cancer Metastatic Hormone Receptor Positive Breast Cancer Hormone Receptor Positive Breast Cancer Endocrine resistant Radioisotope

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A phase 1 imaging study of 68Ga-R10602 in hormone-receptor positive breast cancer.

Official Title

Phase 1 Imaging Study of 68Ga-R10602-101 in Hormone Receptor-Positive Breast Cancer

Quick Facts

Study Start:2024-12-10

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06745804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Breast Cancer Eligibility: 2. At least one measurable target lesion per RECIST 1.1 criteria within 42 days of dosing with 68Ga-R10602. 3. Male or non-pregnant, non-lactating female Study Participant age ≥18 years. Female Study Participant of childbearing potential and male Study Participant (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2. 5. Adequate hepatic function (within 28 days of dosing with 68Ga-R10602) 6. Adequate renal function determined within 28 days of dosing with 68GaR10602. 7. Able to understand and willing to sign an informed consent form.	1. Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R10602. 2. Radiotherapy ≤14 days prior to dosing with 68Ga-R10602. 3. Major surgery ≤21 days prior to dosing with 68Ga-R10602 or has not recovered from adverse effects of such procedure. 4. Severe or unstable medical condition, such as congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE, Version 5.0), myocardial infarction within 6 months prior to starting Investigational Product, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed. 5. History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability. 6. Major active infection requiring antibiotics. 7. Known active human immunodeficiency virus infection or active infection with Hepatitis B or C. 8. Acute illness within 14 days prior to dosing with 68GaR10602 unless mild in severity, as assessed by the Investigator. 9. Any other condition that in the opinion of the Investigator would place the Study Participant at an unacceptable risk or cause the Study Participant to be unlikely to fully participate or comply with study procedures.

Inclusion Criteria

Exclusion Criteria

1. Breast Cancer Eligibility:
2. At least one measurable target lesion per RECIST 1.1 criteria within 42 days of dosing with 68Ga-R10602.
3. Male or non-pregnant, non-lactating female Study Participant age ≥18 years. Female Study Participant of childbearing potential and male Study Participant (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
5. Adequate hepatic function (within 28 days of dosing with 68Ga-R10602)
6. Adequate renal function determined within 28 days of dosing with 68GaR10602.
7. Able to understand and willing to sign an informed consent form.

1. Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R10602.
2. Radiotherapy ≤14 days prior to dosing with 68Ga-R10602.
3. Major surgery ≤21 days prior to dosing with 68Ga-R10602 or has not recovered from adverse effects of such procedure.
4. Severe or unstable medical condition, such as congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE, Version 5.0), myocardial infarction within 6 months prior to starting Investigational Product, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.
5. History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.
6. Major active infection requiring antibiotics.
7. Known active human immunodeficiency virus infection or active infection with Hepatitis B or C.
8. Acute illness within 14 days prior to dosing with 68GaR10602 unless mild in severity, as assessed by the Investigator.
9. Any other condition that in the opinion of the Investigator would place the Study Participant at an unacceptable risk or cause the Study Participant to be unlikely to fully participate or comply with study procedures.

Contacts and Locations

Study Contact

Yael Cohen-Arazi

CONTACT

858-373-7793

R10602-101@radionetics.com

Kristrun Stardal

CONTACT

949-887-9494

R10602-101@radionetics.com

Study Locations (Sites)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Radionetics Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-10

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-12-10

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Hormone Receptor Positive Breast Cancer
Endocrine resistant
Radioisotope

Additional Relevant MeSH Terms

Locoregionally Recurrent Hormone-receptor Positive Breast Cancer
Metastatic Hormone Receptor Positive Breast Cancer