68Ga-R8760 Imaging for Adrenocortical Cancer

No longer recruiting at 1 trial location
IM
AR
Overseen ByAdina Robinson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, 68Ga-R8760, to determine its safety and effectiveness in detecting adrenocortical cancer, a rare cancer of the adrenal gland. Researchers aim to understand how this agent behaves in the body and whether it aids in accurate diagnosis. Individuals with diagnosed adrenocortical carcinoma, particularly those with a measurable tumor, may be suitable for the study. Healthy volunteers are also needed to help assess the imaging agent's effects. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

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 using glucocorticoid steroids (including topical), you must stop at least 4 weeks before the study starts.

Is there any evidence suggesting that 68Ga-R8760 is likely to be safe for humans?

Research shows that specific safety information for 68Ga-R8760 is not yet available. However, compounds like 68Ga are often used in medical imaging and are generally well-tolerated. This study is in its early stages, with the primary goal of determining the safety of 68Ga-R8760 for people. Early studies focus on safety, so researchers will closely monitor any side effects.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about 68Ga-R8760 for adrenocortical cancer because it introduces a novel imaging approach. Unlike traditional treatments that focus on surgery, chemotherapy, or radiation, 68Ga-R8760 uses a radiotracer to help visualize cancerous tissues more precisely. This can potentially lead to better-targeted therapies and improved outcomes for patients. By enhancing the accuracy of imaging, this technique could change how doctors diagnose and monitor this rare cancer.

What evidence suggests that 68Ga-R8760 might be an effective treatment for adrenocortical cancer?

Research has shown that 68Ga-R8760 is a new imaging tool that can help detect cancer in people with adrenocortical carcinoma. This tool attaches to a specific part of the cancer cells called MC2R, often present in these cells. It helps doctors see the cancer more clearly during PET scans, which are special imaging tests. Although researchers are still studying 68Ga-R8760, its ability to identify cancer cells makes it a promising option for better diagnosing and treating this rare and aggressive cancer. Participants in this trial will join either the dose selection phase or the expansion cohort to further evaluate the effectiveness of 68Ga-R8760.24567

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 18-32 and adrenocortical carcinoma (ACC), either newly diagnosed or recurrent, who have at least one measurable lesion. They must be in relatively good health (ECOG ≤2) and have proper liver and kidney function. Participants need to agree to use contraception if applicable, understand the study, and sign consent forms. Exclusions include recent strokes, surgeries, acute illnesses, unstable heart conditions, other cancers that could affect results, certain infections like HIV or hepatitis B/C.

Inclusion Criteria

My liver is functioning within the required limits for the trial.
I have a new or returning adrenal cancer with a measurable tumor.
I can take care of myself but might not be able to do heavy physical work.
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Exclusion Criteria

I haven't donated blood, plasma, or platelets recently.
Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to study Day 1
I have not had radiotherapy in the last 14 days.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Selection

Participants receive varying doses of 68Ga-R8760 to determine optimal dosing

4-6 weeks

Expansion Cohort

Participants receive the selected dose of 68Ga-R8760 for further safety and dosimetry evaluation

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 68Ga-R8760
Trial Overview The Phase 1 trial tests the safety and dosage levels of an injectable radioactive tracer called 68Ga-R8760 in patients with ACC as well as healthy volunteers. The goal is to determine how much of this substance can be safely used while assessing its distribution within the body.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: 68Ga-R8760 Expansion Cohort (Part 2)Experimental Treatment1 Intervention
Group II: 68Ga-R8760 Dose Selection (Part 1)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Radionetics Oncology

Lead Sponsor

Trials
2
Recruited
30+

Published Research Related to This Trial

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

Citations

NCT05999292 | Phase 1 Study of 68Ga-R8760A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers
68Ga-R8760 Imaging for Adrenocortical CancerThis trial is testing a new imaging agent called 68Ga-R8760 to help doctors see cancer cells in patients with Adrenocortical Carcinoma using a PET scan.
targeting MC2R for adrenocortical carcinoma Clinical ...68 Ga-R8760 was discovered by Radionetics Oncology for identifying melanocortin 2 receptor (MC2R)-expressing adrenocortical cancer lesions.
Frontiers in Systemic Therapy for Unresectable or ...Adrenocortical carcinoma is a rare, aggressive endocrine malignancy with limited effective systemic therapy options and an overall poor ...
Adrenocortical Carcinoma (DBCOND0001025) - DrugBankAssociated Data ; NCT00469469. Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma. Bevacizumab ; NCT00786110. Sorafenib Plus Paclitaxel ...
Adrenal Gland/AdrenocorticalA Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers
Phase 1 Study of 68Ga-R8760 - NCIA Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma and Healthy Volunteers. Eligibility Criteria ...
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