- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07625345
Evaluation of [11C]ZTP-1 to Image PDE4B
Background:
PDE4B is a protein in cells that helps turn off certain chemical signals after they ve done their job. It controls inflammation, immune responses, and some brain signaling. Measuring PDE4B levels in the body can help doctors manage a disease or know if a treatment is working. Researchers want to find out if a new tracer (a radioactive substance injected during imaging scans) can help them measure PDE4B in people more effectively.
Objective:
To test a new tracer ([11C]ZTP-1) during imaging scans of the brain and body in healthy people.
Eligibility:
Healthy people aged 18 and older. They must have been screened under protocols 01M-0254 or 17M0181.
Design:
Participants will have either 1 or 2 clinic visits.
During their first visit, all participants will have a positron emission tomography (PET)/computed tomography (CT) scan. Prior to the scan, they will have blood and urine tests and a test of their heart function. The study tracer will be given through a tube attached to a needle inserted into a vein in the arm. They will lie on a padded bed that fits inside a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body.
Some participants will have a PET/CT scan of their whole body. They will need only 1 visit. The visit will last up to about 8 hours.
Some participants will have a PET/CT scan of only their brain. They will also have a magnetic resonance imaging (MRI) scan of the brain. They may need to return for a second visit for the MRI scan.
Participants will receive a follow-up call to check on their well-being after their PET/CT scans.
Visão geral do estudo
Descrição detalhada
Study Description:
This study is intended to provide information on the novel [11C]ZTP-1 radioligand and its ability to localize and measure PDE4B in the brain and body of healthy volunteers.
Objectives:
Primary Objective: To study the brain uptake of [11C]ZTP-1 and perform kinetic modeling of [11C]ZTP-1 in healthy volunteers.
Secondary Objective: To study brain retest variability and reliability, biodistribution, and dosimetry of [11C]ZTP-1 in healthy volunteers.
Endpoint:
Primary Endpoint: PDE4B density measured as distribution volume (VT), derived from kinetic modeling of [11C]ZTP-1 in the brain.
Secondary Endpoint: PDE4B density measured as distribution volume (VT) , evaluated in terms of test retest variability (absolute variability) and reliability (intraclass correlation coefficient [ICC]). Whole-body biodistribution and radiation burden, measured as Effective Dose (ED).)
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Robert B Innis, M.D.
- Número de telefone: (301) 594-1368
- E-mail: robert.innis@nih.gov
Estude backup de contato
- Nome: Tara N Turon, C.R.N.P.
- Número de telefone: (301) 827-6599
- E-mail: tara.turon@nih.gov
Locais de estudo
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- Recrutamento
- National Institutes of Health Clinical Center
-
Contato:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Número de telefone: TTY dial 711 800-411-1222
- E-mail: ccopr@nih.gov
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
- INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet the following criteria:
- Aged 18 years or older.
- Must have undergone a screening assessment under protocol 01M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants or protocol 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies."
- Be healthy based on medical history, physical examination, and laboratory testing.
- Able to provide informed consent.
- Willingness to complete all study procedures including MRI tests.
- Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
- Agree to adhere to the lifestyle considerations
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
- History of neurologic illness or injury with the potential to affect study data interpretation.
- History of seizures, other than in childhood and related to fever.
- Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits.
- Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
- HIV infection.
- Pregnancy or breastfeeding.
- Must not have substance use disorder or alcohol use disorder.
- Unable to travel to the NIH.
- Unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.
- Known hypersensitivity to phosphodiesterase-4 (PDE-4) inhibitors (e.g. apremilast, roflumilast, nerandomilast, crisborole).
- Taking CYP3A4 inhibitors (e.g. grapefruit juice, clarithromycin, erythromycin, ritonavir); CYP3A4 inducers (e.g. phenobarbital St. John's Wort, rifampicin) or oral contraceptives containing gestodene and ethinyl estradiol.
EXCLUSION OF CHILDREN:
Inclusion of children is not appropriate, because this protocol has more than minimal risk from radiation exposure without the possibility of direct benefit.
EXCLUSION OF PREGNANT OR BREASTFEEDING WOMEN:
Pregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk. We will perform a pregnancy test at screening and prior to all procedures to ensure participants are not pregnant. The test must be negative in order to continue on the study. In addition to completing a negative urine pregnancy test, on the day of PET scanning prior to PET scan procedures, participants of childbearing potential will undergo a clinical pregnancy screening interview with a licensed independent practitioner to confirm lack of pregnancy.
EXCLUSION OF PARTICIPANTS WHO ARE HIV POSITIVE:
Persons with HIV infection are excluded because HIV infection itself may change cAMP signaling.
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 |
|---|---|
|
Outro: Um braço
Todos os sujeitos receberão os mesmos testes.
|
Injected IV followed by PET scanning
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total Volume of Distribution
Prazo: 120 minutes
|
Quantification of 11C-ZPT-1
|
120 minutes
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Dosimetry, ICC, aTRV, and biodistribution.
Prazo: 120 minutes
|
Quantification of 11C-ZPT-1
|
120 minutes
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert B Innis, M.D., National Institute of Mental Health (NIMH)
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
Outros números de identificação do estudo
- 10002536
- 002536-M
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .