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Protocol Details

Phase 2 Study Evaluating the Functional Status of the Adrenal Glands with [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001600-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Recruitment has not started
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Children;
Neonates;
Pregnant Women

Keywords

Adenomas;
PET Imaging

Recruitment Keyword(s)

None

Condition(s)

Hyperaldosteronism;
Hypercortisolism;
Cushing s Syndrome

Investigational Drug(s)

Gallium Ga 68-pentixafor

Investigational Device(s)

None

Intervention(s)

Drug: [68Ga]Ga-PentixaFor

Supporting Site

National Cancer Institute

Background:

The adrenal glands are 2 small organs that sit on top of each kidney. They release hormones; these are chemicals that control how the body works. Tumors on or outside the adrenal glands are called functional if they release hormones; they are called nonfunctional if they do not. Doctors who treat adrenal tumors need to know which type a person has. Researchers want to find better ways to learn whether an adrenal tumor is functional.

Objective:

To see if a new radioactive tracer ([68Ga]Ga-PentixaFor) can make it easier to identify functional adrenal tumors with positron emission tomography (PET) scans.

Eligibility:

People aged 18 years and older with 1 or more adrenal tumors. They must have increased levels of the hormones aldosterone or cortisol. They must also be enrolled in at least 1 other related NIH study (protocols 19-DK-0066, 18-CH-0031, or 09-C-0242).

Design:

Participants will be screened. They may have imaging scans. Their ability to perform normal activities will be reviewed.

Participants will have one PET scan with the study tracer.

The tracer will be given through a tube attached to a needle inserted into a vein. Participants will receive the tracer 1 hour before the scan. They will lie still on a bed while a machine captures images of the inside of their body. The scan will take 45 to 90 minutes.

Participants heart rate, blood pressure, and rate of breathing will be checked before, during, and after the scan.

Participants will have a follow-up visit 3 days after their scan. This visit can be by phone, email, or in person.

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Eligibility

INCLUSION CRITERIA:

-Must have either of the following:

--one or more adrenal masses on CT and/or MRI with biochemical evidence of excess aldosterone or ACTH-independent hypercortisolism, OR

--history of ACTH-dependent hypercortisolism (with or without adrenal enlargement)

-Co-enrollment in 19-DK-0066, 09-C-0242, 18-CH-0031 or a similar NIH trial.

-Age >=18 years.

-ECOG performance status <= 2.

-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.

--Breastfeeding should be discontinued for one week after the [68Ga]Ga-PentixaFor scan.

--Men must agree not to donate sperm for one week after the [68Ga]Ga-PentixaFor scan.

-Participants must be able to understand and willing to sign a written informed consent document.

EXCLUSION CRITERIA:

-Positive beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.

-Uncontrolled intercurrent illness or social situations based on the review of medical history that would limit compliance with study requirements.

-Contraindications to having an MRI and CT.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Maria Liza Lindenberg, M.D.
National Cancer Institute (NCI)
BG 10 RM B3B47A
10 CENTER DR
BETHESDA MD 20814
(240) 760-6109
liza.lindenberg@mail.nih.gov

Yolanda McKinney, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B3B69E
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6095
ymckinney@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT06246357

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