Radioactive Tracer for Cushing's Syndrome

Phase 2

Recruiting

Led By Maria Liza Lindenberg, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Women of child-bearing potential (WOCBP) and men must agree to use an effective contraception (barrier, hormonal, intrauterine device [IUD], surgical sterilization, abstinence) for two weeks prior to [68Ga]Ga-PentixaFor scan and for one week after the [68Ga]Ga-PentixaFor scan

Age >=18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 year following [68ga]ga-pentixafor imaging

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new radioactive tracer to help identify adrenal tumors that release hormones. Participants will receive the tracer through a vein and undergo a PET scan to capture images of their body. Researchers will

Who is the study for?

This trial is for adults over 18 with adrenal tumors that produce excess hormones, specifically aldosterone or cortisol. Participants must also be part of other related NIH studies and have the ability to perform normal activities.

What is being tested?

[68Ga]Ga-PentixaFor, a new radioactive tracer, is being tested to see if it improves the detection of functional adrenal tumors using PET scans. Patients will undergo one scan after receiving the tracer intravenously.

What are the potential side effects?

Potential side effects may include reactions at the injection site, changes in heart rate, blood pressure fluctuations, and altered breathing rates during and after the PET scan.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use effective birth control before and after my scan.

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I am 18 years old or older.

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

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I have adrenal masses and high aldosterone or cortisol levels, or a history of ACTH-dependent high cortisol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 year following [68ga]ga-pentixafor imaging

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 year following [68ga]ga-pentixafor imaging

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year following [68ga]ga-pentixafor imaging for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism

Secondary study objectives

Compare [68Ga]Ga-PentixaFor uptake to C-X-C chemokine receptor type 4 (CXCR4) expression in resected tissue (when obtained on parent protocol)

Estimate the safety of [68Ga]Ga-PentixaFor

Evaluate threshold values of [68Ga]Ga-PentixaFor uptake for determining adrenal mass hyperfunction