Avaliando o status funcional das glândulas supra-renais com [68Ga]Ga-PentixaFor no hiperaldosteronismo e hipercortisolismo
Estudo de fase 2 avaliando o status funcional das glândulas supra-renais com [68Ga]Ga-PentixaFor no hiperaldosteronismo e hipercortisolismo
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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)
-
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).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Maria Liza Lindenberg, M.D.
- Número de telefone: (240) 760-6109
- E-mail: liza.lindenberg@mail.nih.gov
Estude backup de contato
- Nome: Yolanda L McKinney, R.N.
- Número de telefone: (240) 760-6095
- E-mail: ymckinney@mail.nih.gov
Locais de estudo
-
-
Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- Recrutamento
- National Institutes of Health Clinical Center
-
Contato:
- National Cancer Institute Referral Office
- Número de telefone: 888-624-1937
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
-
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)
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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.
-
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Compare [68Ga]Ga-PentixaFor uptake to C-X-C chemokine receptor type 4 (CXCR4) expression in resected tissue (when obtained on parent protocol)
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maria Liza Lindenberg, M.D., National Cancer Institute (NCI)
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10001600
- 001600-C
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
All IPD recorded in the medical record will be shared with intramural investigators upon request.
Prazo de Compartilhamento de IPD
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.
Critérios de acesso de compartilhamento IPD
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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