22 Participants Needed

68Ga-R10602 Imaging for Breast Cancer

Recruiting at 2 trial locations
YC
KS
Overseen ByKristrun Stardal
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Radionetics Oncology
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment 68Ga-R10602 for breast cancer?

The use of 68Ga in imaging has shown promise in detecting and managing various cancers, including breast cancer, by providing detailed images that help in diagnosing and planning treatment. Similar 68Ga-based imaging agents have been effective in visualizing tumors and metastases, suggesting potential for 68Ga-R10602 in breast cancer imaging.12345

Is 68Ga-R10602 safe for use in humans?

The safety of 68Ga-based radiopharmaceuticals, like 68Ga-R10602, is generally supported by their use in diagnostic imaging, where they provide high-resolution images with acceptable radiation doses for patients.15678

How is the drug 68Ga-R10602 different from other breast cancer treatments?

68Ga-R10602 is unique because it uses gallium-68, a radionuclide, for imaging in positron emission tomography (PET), which can provide higher-resolution images compared to traditional imaging agents. This approach helps in better visualization and management of breast cancer, especially in cases with suspected metastases.12456

What is the purpose of this trial?

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

Eligibility Criteria

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.
See 5 more

Exclusion Criteria

I haven't had major surgery in the last 3 weeks or still recovering from one.
I haven't had a radionuclide treatment recently.
I haven't had a severe illness in the last 2 weeks.
See 6 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: 68Ga-R10602 Imaging Optimization Portion (Cohort 1)Experimental Treatment1 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 Treatment1 Intervention
68Ga-R10602 injection at the selected dose level. PET/CT imaging at a single timepoint.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Radionetics Oncology

Lead Sponsor

Trials
2
Recruited
30+

Findings from Research

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.
68Ga-Based radiopharmaceuticals: production and application relationship.Velikyan, I.[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.
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]
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.
68Ga-P15-041, A Novel Bone Imaging Agent for Diagnosis of Bone Metastases.Guo, R., Meng, X., Wang, F., et al.[2022]

References

68Ga-Based radiopharmaceuticals: production and application relationship. [2022]
Gastrin-Releasing Peptide Receptor Antagonist [68Ga]RM2 PET/CT for Staging of Pre-Treated, Metastasized Breast Cancer. [2021]
68Ga-P15-041, A Novel Bone Imaging Agent for Diagnosis of Bone Metastases. [2022]
Prospective of 68Ga Radionuclide Contribution to the Development of Imaging Agents for Infection and Inflammation. [2019]
(68)Ga-labeled radiopharmaceuticals for positron emission tomography. [2021]
Good practices for 68Ga radiopharmaceutical production. [2022]
The untapped potential of Gallium 68-PET: the next wave of ⁶⁸Ga-agents. [2022]
Convenient Formulation of 68Ga-BPAMD Patient Dose Using Lyophilized BPAMD Kit and 68Ga Sourced from Different Commercial Generators for Imaging of Skeletal Metastases. [2019]
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