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Radiopharmaceutical

1/[68Ga]Ga-PentixaFor PET/CT or PET/MR for Cushing's Syndrome

Phase 2

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/[68Ga]Ga-PentixaFor PET/CT or PET/MRExperimental Treatment1 Intervention

Participants will undergo [68Ga]Ga-PentixaFor PET/CT or PET/MR

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,996 Total Patients Enrolled

Maria Liza Lindenberg, M.D.Principal InvestigatorNational Cancer Institute (NCI)

3 Previous Clinical Trials

116 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of 1/[68Ga]Ga-PentixaFor for PET imaging in patients undergoing either a PET/CT or PET/MR scan?

"Given the phase 2 nature of this trial, our evaluation at Power suggests that the safety rating for 1/[68Ga]Ga-PentixaFor PET/CT or PET/MR falls at a level of 2. This indicates some existing safety data but lacks evidence in terms of efficacy."

Answered by AI

Which individuals meet the eligibility criteria for participating in this research endeavor?

"Individuals aged 18 to 120 years diagnosed with primary aldosteronism are sought for this study, which aims to recruit approximately 77 eligible participants."

Answered by AI

Are there still opportunities for patients to participate in this ongoing research study?

"As indicated on clinicaltrials.gov, this specific medical investigation is no longer accepting new participants. Despite being first posted on 2/12/2024 and last revised on 2/6/2024, there are currently 45 alternative trials actively seeking volunteers."

Answered by AI

Is the age criterion for potential participants in this medical study restricted to individuals above 45 years old?

"Participants must be aged between 18 and 120 to qualify for this research study. There are separate trials available for individuals under 18 years old (10 trials) and those over 65 years old (35 trials)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism

2024. "Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06246357.

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