What side effects are associated with this type of intervention?

Common treatments for Adrenocortical Cancer include chemotherapy, targeted therapies, and radiopharmaceuticals. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infections. Targeted therapies may lead to hypertension, hypokalemia, and liver function abnormalities. Radiopharmaceuticals, like those used in PET imaging, can cause mild to moderate side effects including nausea, headache, and injection site reactions. It's important to discuss potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments specifically for Adrenocortical Cancer that are similar to the radiopharmaceutical 68Ga-R8760 used for PET imaging. Generally, treatments for Adrenocortical Cancer include surgical resection, mitotane (an adrenolytic agent), and other systemic therapies such as chemotherapy with agents like etoposide, doxorubicin, and cisplatin. Radiopharmaceuticals for PET imaging, like 68Ga-R8760, are still under investigation and not yet widely approved for this specific cancer type.

What other types of research exist?

Promising alternatives to 68Ga-R8760 for PET imaging in Adrenocortical Cancer patients include Lutetium Lu-177 dotatate and somatostatin analogs like octreotide and lanreotide. These agents have shown efficacy in imaging and treating neuroendocrine tumors, which may offer potential benefits for ACC patients.

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Radiopharmaceutical

68Ga-R8760 Imaging for Adrenocortical Cancer

Phase 1

Waitlist Available

Research Sponsored by Radionetics Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate hepatic function as defined below: Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present or received prior mitotane therapy, and Serum bilirubin - total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN)

Newly diagnosed or recurrent/relapsed ACC with at least 1 measurable target lesion per RECIST v1.1 criteria

Must not have

Major surgery ≤21 days prior to study Day 1 or has not recovered from adverse effects of such procedure

Prior unilateral or bilateral adrenalectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to injection such as pain or swelling at the injection site. Since it's a radioactive substance being tested for safety/dosage levels, there might also be risks associated with radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver is functioning within the required limits for the trial.

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I have a new or returning adrenal cancer with a measurable tumor.

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I am an adult over 18 and not pregnant or breastfeeding if female.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer is confirmed to be adrenal cortical carcinoma.

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I am a healthy adult between 18 and 59 years old and not pregnant or breastfeeding.

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My kidneys work well, with a creatinine clearance of 60 mL/min or more.

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My kidneys are working well, with a creatinine clearance of 60 mL/min or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had surgery to remove one or both of my adrenal glands.

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I am currently on antibiotics for a serious infection.

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My heart's electrical system does not have long QT syndrome and my QTcF is within normal range.

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I do not have severe heart problems or uncontrolled health conditions.

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I don't have another cancer that would affect the safety of this trial.

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I do not have an active HIV, Hepatitis B, or Hepatitis C infection.

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I am not mentally or legally incapacitated.

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I have been diagnosed with an adrenal gland disorder.

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I had a stroke within the last 6 months or it caused lasting neurological issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Adrenocortical Cancer (ACC) include surgical resection, mitotane, chemotherapy, and radiopharmaceuticals. Surgical resection aims to remove the tumor entirely, which is crucial for localized ACC. Mitotane, an adrenolytic agent, works by inhibiting steroidogenesis and causing adrenal cortex cell death, which is particularly useful for metastatic or recurrent ACC. Chemotherapy, often using agents like etoposide, doxorubicin, and cisplatin, targets rapidly dividing cancer cells. Radiopharmaceuticals, such as 68Ga-R8760 used in PET imaging, bind to specific receptors or proteins on cancer cells, allowing for precise imaging and targeted radiotherapy. These mechanisms are vital for ACC patients as they offer a multi-faceted approach to manage and treat the disease, improving diagnostic accuracy, treatment efficacy, and overall prognosis.