68Ga-R10602 Imaging for Breast Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

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

Trial Summary

What is the purpose of this trial?

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

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.

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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.

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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.

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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.

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.

Trial 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)

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Indiana University Melvin and Bren Simon Cancer Center Indianapolis, IN

University of Michigan Medicine Ann Arbor, MI

Who Is Running the Clinical Trial?

Radionetics Oncology Lead Sponsor

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

68Ga-Based radiopharmaceuticals: production and application relationship. [2022] The contribution of 68Ga to the promotion and expansion of clinical research and routine positron emission tomography (PET) for earlier better diagnostics and individualized medicine is considerable. The potential applications of 68Ga-comprising imaging agents include targeted, pre-targeted and non-targeted imaging. This review discusses the key aspects of the production of 68Ga and 68Ga-based radiopharmaceuticals in the light of the impact of regulatory requirements and endpoint pre-clinical and clinical applications.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Gastrin-Releasing Peptide Receptor Antagonist [68Ga]RM2 PET/CT for Staging of Pre-Treated, Metastasized Breast Cancer. [2021] Label="BACKGROUND" NlmCategory="BACKGROUND">Positron emission tomography (PET)/computed tomography (CT) using the gastrin-releasing peptide receptor antagonist [68Ga]RM2 has shown to be a promising imaging method for primary breast cancer (BC) with positive estrogen receptor (ER) status. This study assessed tumor visualization by [68Ga]RM2 PET/CT in patients with pre-treated ER-positive BC and suspected metastases.

3. Switzerland pubmed.ncbi.nlm.nih.gov

68Ga-P15-041, A Novel Bone Imaging Agent for Diagnosis of Bone Metastases. [2022] Label="OBJECTIVES" NlmCategory="OBJECTIVE"> 68Ga-P15-041 (68Ga-HBED-CC-BP) is a novel bone-seeking PET radiotracer, which can be readily prepared by using a simple kit formulation and an in-house 68Ga/68Ge generator. The aim of this study is to assess the potential human application of 68Ga-P15-041 for clinical PET/CT imaging and to compare its efficacy to detect bone metastases of different cancers with 99mTc-MDP whole-body bone scintigraphy (WBBS).

4. England pubmed.ncbi.nlm.nih.gov

Prospective of 68Ga Radionuclide Contribution to the Development of Imaging Agents for Infection and Inflammation. [2019] During the last decade, the utilization of 68Ga for the development of imaging agents has increased considerably with the leading position in the oncology. The imaging of infection and inflammation is lagging despite strong unmet medical needs. This review presents the potential routes for the development of 68Ga-based agents for the imaging and quantification of infection and inflammation in various diseases and connection of the diagnosis to the treatment for the individualized patient management.

5. Germany pubmed.ncbi.nlm.nih.gov

(68)Ga-labeled radiopharmaceuticals for positron emission tomography. [2021] (68)Ga is a promising emerging radionuclide for positron emission tomography (PET). It is produced using a (68)Ge/(68)Ga-generator, and thus, would enable the cyclotron-independent distribution of PET. However, new (68)Ga-labeled radiopharmaceuticals that can replace (18)F-labeled agents like [(18)F]fluorodeoxyglucose (FDG) are needed. Most of the (68)Ga-labeled derivatives currently used are peptide agents, but the developments of other agents, such as amino acid derivatives, nitroimidazole derivatives, and glycosylated human serum albumin, are being actively pursued in many laboratories. Thus, appearance of new (68)Ga-labeled radiopharmaceuticals with high impact are expected in the near future. Here, we present an overview of (68)Ga-labeled agents in terms of their clinical significances and relevances to the management of certain tumors, and pertinent pre-clinical developments.

6. England pubmed.ncbi.nlm.nih.gov

Good practices for 68Ga radiopharmaceutical production. [2022] Label="BACKGROUND" NlmCategory="BACKGROUND">The radiometal gallium-68 (68Ga) is increasingly used in diagnostic positron emission tomography (PET), with 68Ga-labeled radiopharmaceuticals developed as potential higher-resolution imaging alternatives to traditional 99mTc agents. In precision medicine, PET applications of 68Ga are widespread, with 68Ga radiolabeled to a variety of radiotracers that evaluate perfusion and organ function, and target specific biomarkers found on tumor lesions such as prostate-specific membrane antigen, somatostatin, fibroblast activation protein, bombesin, and melanocortin.

7. England pubmed.ncbi.nlm.nih.gov

The untapped potential of Gallium 68-PET: the next wave of ⁶⁸Ga-agents. [2022] (68)Gallium-PET ((68)Ga-PET) agents have significant clinical promise. The radionuclide can be produced from a (68)Ge/(68)Ga generator on site and is a convenient alternative to cyclotron-based PET isotopes. The short half-life of (68)Ga permits imaging applications with sufficient radioactivity while maintaining patient dose to an acceptable level. Furthermore, due to superior resolution, (68)Ga-PET agents have the ability to replace current SPECT agents in many applications. This article outlines the upcoming agents and challenges faced during the translational development of (68)Ga agents.

8. United States 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. [2019] Label="PURPOSE" NlmCategory="OBJECTIVE"> 68Ga-BPAMD has recently emerged as one of the preferred radiopharmaceuticals for imaging of bone lesions due to its ability to produce high-resolution images and uncomplicated availability of 68Ga, a positron emission tomography (PET) radionuclide, from commercial 68Ge/68Ga generators. The primary objective of this work is to develop freeze-dried BPAMD kit, for the easy and convenient formulation of 68Ga-BPAMD patient dose at the hospital radiopharmacy. In addition, the kit should be compatible with 68Ga, eluted using HCl of various molarities from the 68Ge/68Ga generators sourced from different suppliers.