68Ga-R10602 Imaging for Breast Cancer

Recruiting at 5 trial locations

Overseen By Kristrun Stardal

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Radionetics Oncology

Must be taking: Endocrine therapy

Must not be taking: Radionuclides

Disqualifiers: Congestive heart failure, Ischemic heart disease, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 week

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method using 68Ga-R10602, an imaging agent, to better understand hormone-receptor positive breast cancer. The goal is to evaluate the effectiveness of this imaging agent in various settings, particularly for those whose cancer has not responded to hormone treatments. Participants will receive an injection of the imaging agent and then undergo PET/CT scans to assess its effectiveness. Ideal candidates have hormone-receptor positive breast cancer that is not responding to treatment and have tried at least one type of chemotherapy. As a Phase 1 trial, this research aims to understand how the imaging agent works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are starting a new line of therapy that includes certain drugs, you must be imaged while on single-agent endocrine therapy before starting any targeted therapy.

What prior data suggests that 68Ga-R10602 is safe for imaging in breast cancer?

Research shows that 68Ga-R10602 is under investigation for its safety in imaging breast cancer. As an early-phase study, the primary goal is to assess how well participants tolerate the treatment and identify any side effects.

In such studies, doctors closely monitor patients for any unwanted or harmful reactions. Currently, specific safety information about 68Ga-R10602 from these studies is not available. However, as an early-phase trial, the focus is on ensuring its safety for participants.

Researchers carefully observe participants to ensure no major safety concerns arise. If serious safety issues were detected, the study would typically be paused or stopped. The ongoing nature of the study suggests that no major safety problems have emerged so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 68Ga-R10602 imaging technique for breast cancer because it uses a novel radiotracer, 68Ga-R10602, which could provide clearer, more precise images of cancerous tissues. Unlike standard imaging methods, this approach leverages PET/CT technology to potentially detect tumors earlier and with greater accuracy. This could lead to more tailored treatment plans, improving outcomes by catching cancer in its early stages.

What evidence suggests that 68Ga-R10602 is effective for imaging hormone-receptor positive breast cancer?

Research shows that 68Ga-R10602 is being tested in this trial to improve imaging for breast cancer with hormone receptors. This imaging agent enhances PET/CT scans, helping doctors see tumors more clearly. Previous studies have demonstrated that similar imaging agents can accurately identify breast cancer. For example, 68Ga-HER2 affibody PET/CT correctly identified certain types of breast cancer 91.7% of the time. These early results suggest that 68Ga-R10602 could effectively detect and monitor breast cancer. Participants in this trial will receive 68Ga-R10602 injections, with imaging conducted at pre-defined timepoints to optimize and confirm its effectiveness. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with hormone-receptor positive breast cancer that's either locally recurrent or metastatic and not removable by surgery. Participants must have tried at least one endocrine therapy, have good liver and kidney function, a measurable tumor, and agree to use contraception. Exclusions include recent major surgery, radionuclide treatment, acute illness, unstable heart conditions, active infections like HIV or hepatitis B/C.

Inclusion Criteria

My liver is working well.

I can understand and am willing to sign a consent form.

My kidney function is good as tested within the last 28 days.

Exclusion Criteria

I haven't had major surgery in the last 3 weeks or still recovering from one.

I haven't had a severe illness in the last 2 weeks.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of 68Ga-R10602 followed by imaging and blood dosimetry

1 week

5 imaging visits, 7 dosimetry visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-R10602

Trial Overview The study tests an imaging agent called 68Ga-R10602 in patients with advanced breast cancer. It's a phase 1 trial focusing on how the body processes the agent and its safety. The participants are divided into two cohorts based on their previous treatments and current medication plans.

How Is the Trial Designed?

Group I: 68Ga-R10602 Imaging Optimization Portion (Cohort 1) Experimental Treatment 1 Intervention

68Ga-R10602 injection at pre-defined dose levels. PET/CT imaging at pre-defined timepoints.

Group II: 68Ga-R10602 Imaging Confirmation Portion (Cohort 2) Experimental Treatment 1 Intervention

68Ga-R10602 injection at the selected dose level. PET/CT imaging at a single timepoint.

Who Is Running the Clinical Trial?

Radionetics Oncology

Lead Sponsor

Trials

2

Recruited

30+

Published Research Related to This Trial

Gallium-68 (68Ga) radiopharmaceuticals are emerging as effective alternatives to traditional 99mTc agents for high-resolution imaging in PET scans, with applications in evaluating organ function and targeting specific tumor biomarkers.

The review emphasizes the importance of standardized production and quality control methods for 68Ga radiopharmaceuticals, which are crucial for their safe and effective clinical use, given their favorable properties like short half-life and ease of radiolabeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good practices for 68Ga radiopharmaceutical production. Nelson, BJB., Andersson, JD., Wuest, F., et al.[2022]

The use of 68Ga in imaging agents has significantly increased in oncology, but its application in imaging infections and inflammation remains underdeveloped despite high medical demand.

This review highlights potential pathways for creating 68Ga-based imaging agents that could improve diagnosis and treatment management for patients with infections and inflammatory diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective of 68Ga Radionuclide Contribution to the Development of Imaging Agents for Infection and Inflammation. Velikyan, I.[2019]

68Ga-based imaging agents significantly enhance the capabilities of positron emission tomography (PET) for improved diagnostics and personalized medicine.

The review highlights the importance of regulatory requirements in the production and application of 68Ga radiopharmaceuticals, which are crucial for both pre-clinical and clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Based radiopharmaceuticals: production and application relationship. Velikyan, I.[2022]

(68)Gallium-PET agents are promising for clinical use because they can be produced on-site from a (68)Ge/(68)Ga generator, making them more accessible than traditional cyclotron-based PET isotopes.

The short half-life of (68)Ga allows for effective imaging with minimal radiation exposure to patients, and its superior resolution suggests it could replace current SPECT agents in various medical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The untapped potential of Gallium 68-PET: the next wave of ⁶⁸Ga-agents. Smith, DL., Breeman, WA., Sims-Mourtada, J.[2022]

The novel radiotracer 68Ga-P15-041 PET/CT demonstrated superior efficacy in detecting bone metastases compared to the traditional 99mTc-MDP whole-body bone scintigraphy, identifying 162 metastatic sites versus 81, with higher sensitivity (93.1% vs 81.8%) and accuracy (90.7% vs 88.4%).

68Ga-P15-041 PET/CT provides rapid imaging with high contrast and quantitative data, making it a promising routine procedure for detecting bone metastases in cancer patients, especially in settings where other radiotracers like 18F fluoride are unavailable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-P15-041, A Novel Bone Imaging Agent for Diagnosis of Bone Metastases. Guo, R., Meng, X., Wang, F., et al.[2022]

In a pilot study of eight women with pre-treated ER-positive breast cancer, [68Ga]RM2 PET/CT imaging successfully identified strong binding in metastatic lesions in 75% of patients, indicating its potential effectiveness for visualizing tumors.

The study found that RM2-positive metastases had a significantly higher mean standardized uptake value (SUVmax) compared to RM2-negative metastases, suggesting that [68Ga]RM2 PET/CT could aid in treatment decisions and planning for patients with advanced breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrin-Releasing Peptide Receptor Antagonist [68Ga]RM2 PET/CT for Staging of Pre-Treated, Metastasized Breast Cancer. Michalski, K., Kemna, L., Asberger, J., et al.[2021]

(68)Ga is a promising radionuclide for PET imaging that can be produced without a cyclotron, allowing for easier distribution of PET scans.

There is ongoing research into new (68)Ga-labeled radiopharmaceuticals, including amino acid and nitroimidazole derivatives, which may provide effective alternatives to current (18)F-labeled agents like FDG for tumor management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(68)Ga-labeled radiopharmaceuticals for positron emission tomography. Shetty, D., Lee, YS., Jeong, JM.[2021]

The developed freeze-dried BPAMD kit allows for the preparation of 68Ga-BPAMD with over 95% radiochemical purity, making it a reliable option for imaging bone lesions in patients.

Clinical studies demonstrated that 68Ga-BPAMD effectively accumulates in bone lesions of patients with metastatic bone cancer, indicating its potential for accurate PET scanning of skeletal metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Convenient Formulation of 68Ga-BPAMD Patient Dose Using Lyophilized BPAMD Kit and 68Ga Sourced from Different Commercial Generators for Imaging of Skeletal Metastases. Guleria, M., Das, T., Amirdhanayagam, J., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06745804

Study Details | NCT06745804 | Study of 68Ga-R10602 In Cohort 2, approximately six to eight patients will receive the single chosen dose followed by imaging at five timepoints and blood dosimetry ...

2. theranostictrials.org theranostictrials.org/studies/cl74bp9il0231ajjf2950vuef

Breast The aim of this study is to compare the diagnostic performance of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT in primary and metastatic lesions of breast cancer and ...

3. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/12989/phase-1-imaging-study/

Phase 1 Imaging Study of 68Ga-R10602 in Hormone This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen receptor-positive breast cancer.

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/564136

Study of 68Ga-R10602 - Carebox Connect Number and location of tumor lesions identified by 68Ga-R10602 PET/CT and by standard of care imaging (e.g. contrast enhanced diagnostic CT) and concordance ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9195516/

Application of a Novel 68Ga-HER2 Affibody PET/CT Imaging ... 68 Ga-HER2 affibody PET/CT demonstrated a high diagnostic accuracy in differentiating HER2-enriched breast cancer, with a sensitivity of 91.7% and a ...

6. cancer.iu.edu cancer.iu.edu/patients/clinical-trials/63477

CTO-R10602-101: Clinical Trial Information Information about IUSCCC Clinical Trial CTO-R10602-101: Phase 1 Imaging Study of 68Ga-R10602 in Hormone Receptor-Positive Breast Cancer.