68Ga-R8760 Imaging for Adrenocortical Cancer

Recruiting at 1 trial location

Overseen By Adina Robinson

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Radionetics Oncology

Must not be taking: Glucocorticoids

Disqualifiers: Congestive heart failure, Uncontrolled hypertension, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

11 Participants Needed

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

What data supports the effectiveness of the treatment 68Ga-R8760 for adrenocortical cancer?

The research on similar treatments like 68Ga-DOTAGA-IAC PET/CT shows promise in imaging adrenocortical cancer by providing a clear view of the tumor, which can help in managing the disease. This suggests that 68Ga-R8760 might also be effective in improving the detection and management of adrenocortical cancer. ^{1 2 3 4 5}

Is 68Ga-R8760 safe for use in humans?

There is no specific safety data available for 68Ga-R8760, but 68Ga-labeled compounds are widely used in medical imaging and are generally considered safe. However, detailed safety information for each specific compound may vary and should be confirmed with healthcare providers. ^{6 7 8 9 10}

What makes 68Ga-R8760 unique for treating adrenocortical cancer?

68Ga-R8760 is a novel imaging agent that may offer a more specific way to visualize adrenocortical cancer compared to traditional imaging methods. It is similar to 68Ga-DOTAGA-IAC, which targets specific proteins on cancer cells, potentially improving the detection of metastatic and recurrent tumors. ^{1 3 11 12 13}

What is the purpose of this trial?

This 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. It also includes healthy volunteers to understand how the agent works in people without cancer. 68Ga has been widely used in clinical research and routine PET for better diagnostics and personalized medicine.

Eligibility Criteria

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.

Exclusion Criteria

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 haven't donated blood, plasma, or platelets recently.

I have not had radiotherapy in the last 14 days.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: 68Ga-R8760 Expansion Cohort (Part 2) Experimental Treatment 1 Intervention

Group II: 68Ga-R8760 Dose Selection (Part 1) Experimental Treatment 1 Intervention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

68Ga-DOTAGA-IAC PET/CT for Imaging Metastatic and Recurrent Adrenocortical Carcinoma: A Case Series. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Molecular Imaging in the Management of Adrenocortical Cancer: A Systematic Review. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Ga-67 scintigraphy in a child with adrenocortical carcinoma. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Adrenocortical cancer update. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Scintigraphic detection of hepatic metastases with 131I-labeled steroid in recurrent adrenal carcinoma: case report. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Good practices for 68Ga radiopharmaceutical production. [2022]

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]

9. England pubmed.ncbi.nlm.nih.gov

Dosimetry of [⁶⁸Ga]-labeled compounds. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Initial Clinical Experience with 68Ga-DOTA-NOC Prepared Using 68Ga from Nanoceria-polyacrylonitrile Composite Sorbent-based 68Ge/68Ga Generator and Freeze-dried DOTA-NOC Kits. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Targeting 11-Beta Hydroxylase With [131I]IMAZA: A Novel Approach for the Treatment of Advanced Adrenocortical Carcinoma. [2022]

12. England pubmed.ncbi.nlm.nih.gov

18F-FDG PET/CT in the post-operative monitoring of patients with adrenocortical carcinoma. [2022]

13. China pubmed.ncbi.nlm.nih.gov

[Comprehensive treatment of adrenal cortical carcinoma]. [2020]