고알도스테론증 및 고코르티솔증에서 [68Ga]Ga-PentixaFor를 사용한 부신의 기능적 상태 평가
고알도스테론증 및 고코르티솔증에서 [68Ga]Ga-PentixaFor를 사용하여 부신의 기능 상태를 평가하는 2상 연구
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.
연구 개요
상세 설명
Background:
- [68Ga]Ga-PentixaFor is a PET agent targeting the C-X-C chemokine receptor type 4 (CXCR4) with promising applications in oncology, cardiology, and infectious disease.
- CXCR4 has also been noted to show high expression in many aldosterone-producing adenomas (APA) and some cortisol-producing adenomas (CPA) but not usually in nonfunctioning adenomas.
- [68Ga]Ga-PentixaFor may be useful in the evaluation of adrenal adenomas in the setting of Conn's or Cushing's syndrome. Localizing functional adenomas is important for managing treatment options but current imaging modalities are either too invasive or insufficiently able to differentiate adrenal conditions.
Objective:
-To estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism
Eligibility:
-
Must have any of the following:
- one or more adrenal masses on CT and/or MRI and biochemical evidence of excess aldosterone or
- ACTH-independent hypercortisolism with or without adrenal masses on CT and/or MRI or
- history of ACTH-dependent hypercortisolism (with or without adrenal enlargement)
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Age >= 18 years
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ECOG performance status <= 2
Design:
- This is a Phase II, single site study where participants from three cohorts are enrolled into one arm according to their probable disease: primary aldosteronism (Cohort 1), ACTHindependent Cushing's syndrome (Cohort 2), or ACTH-dependent Cushing's syndrome (Cohort 3).
- All participants will undergo a [68Ga]Ga-PentixaFor PET/CT or [68Ga]Ga-PentixaFor PET/MR.
- A safety visit will be performed 3 days following the [68Ga]Ga-PentixaFor imaging.
- Participants will remain on-study for up to 1 year to allow the collection of samples for correlative analysis from the parent protocol (adrenal venous sampling, imaging assessments, laboratory evaluations, and/or tissue samples).
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Maria Liza Lindenberg, M.D.
- 전화번호: (240) 760-6109
- 이메일: liza.lindenberg@mail.nih.gov
연구 연락처 백업
- 이름: Yolanda L McKinney, R.N.
- 전화번호: (240) 760-6095
- 이메일: ymckinney@mail.nih.gov
연구 장소
-
-
Maryland
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Bethesda, Maryland, 미국, 20892
- 모병
- National Institutes of Health Clinical Center
-
연락하다:
- National Cancer Institute Referral Office
- 전화번호: 888-624-1937
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
-
INCLUSION CRITERIA:
-
Must have any of the following:
- one or more adrenal masses on CT and/or MRI and biochemical evidence of excess aldosterone
OR
--ACTH-independent hypercortisolism, with or without adrenal masses on CT and/or MRI
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.
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Age >=18 years.
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ECOG performance status <= 2.
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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.
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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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 1/[68Ga]Ga-PentixaFor PET/CT or PET/MR
Participants will undergo [68Ga]Ga-PentixaFor PET/CT or PET/MR |
[68Ga]Ga-PentixaFor will be injected intravenously approximately 60 minutes prior to scanning at a dose of 150 +/- 50 MBq (4 mCi +/- 1.4). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism
기간: Screening
|
The percent concordance between [68Ga]Ga-PentixaFor and clinical diagnosis will be estimated within each Cohort, along with 90% Clopper-Pearson confidence intervals. |
Screening
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Compare [68Ga]Ga-PentixaFor uptake to C-X-C chemokine receptor type 4 (CXCR4) expression in resected tissue (when obtained on parent protocol)
기간: Within 1 year following [68Ga]Ga-PentixaFor imaging
|
The Spearman rank correlation coefficient between [68Ga]Ga-PentixaFor PET parameters (SUVmax, SUVmean, TLU, TV) and CXCR4 expression as measured via immunohistochemistry will be estimated within each Cohort. |
Within 1 year following [68Ga]Ga-PentixaFor imaging
|
|
Evaluate threshold values of [68Ga]Ga-PentixaFor uptake for determining adrenal mass hyperfunction
기간: Within 1 year following [68Ga]Ga-PentixaFor imaging
|
Receiver operating characteristic (ROC) curves of [68Ga]Ga-PentixaFor SUVmax in detecting adrenal mass hyperfunction will be constructed. The cutoff associated with the highest Youden index (sensitivity plus specificity) will be selected as the optimal threshold. |
Within 1 year following [68Ga]Ga-PentixaFor imaging
|
|
Estimate the safety of [68Ga]Ga-PentixaFor
기간: Day of [68Ga]Ga-PentixaFor administration until end of study participation
|
Safety will be evaluated by determining the frequency of adverse events among participants and reporting the results, by maximum grade of event and type of toxicity noted. |
Day of [68Ga]Ga-PentixaFor administration until end of study participation
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Maria Liza Lindenberg, M.D., National Cancer Institute (NCI)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 10001600
- 001600-C
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All IPD recorded in the medical record will be shared with intramural investigators upon request.
IPD 공유 기간
This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review.
IPD 공유 액세스 기준
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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