Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This single-site, single-arm study will evaluate the accuracy of active bone marrow (ABM) segmentation with CSE-MRI by comparing to the established technique of FLT PET in patients with PSMA+ mCRPC who are scheduled to receive Lutetium-177 Prostate-Specific Membrane Antigen (177Lu-PSMA) (PLUVICTO®) Radiopharmaceutical Therapy (RPT) as standard of care. All standard of care testing, monitoring, and administration for 177Lu-PSMA RPT (PLUVICTO®) will be followed for this study.
Participants will receive 177Lu-PSMA RPT (PLUVICTO®) for a total of 6 doses, or until disease progression or unacceptable toxicity. Doses of 177Lu-PSMA RPT will be given at least 6 weeks apart. At the discretion of the prescribing physician, standard of care PSMA PET/MRI will be performed at any time during cycles 2-4, and also within 6 months of the final administration of 177Lu-PSMA RPT; during these scans, the CSE-MRI will also be acquired. Participants will be followed for 6 months following the final administration of 177Lu-PSMA RPT.
The primary endpoint is a calculation of the mean Dice similarity coefficient (DSC) between active bone marrow volumes derived from CSE-MRI and ¹⁸F-FLT PET across all enrolled patients. A mean DSC of ≥0.7 will indicate that CSE-MRI is a clinically acceptable alternative to FLT PET for identifying ABM.
With the exception of the research-related CSE-MRI and FLT PET scans, all assessments, laboratory tests, RPT, and imaging scans are standard of care.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase inicial 1
Contactos e Locais
Contato de estudo
- Nome: Cancer Connect
- Número de telefone: 800-622-8922
- E-mail: clinicaltrials@cancer.wisc.edu
Locais de estudo
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Carbone Cancer Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must be informed of the experimental nature of the study and its potential risks, and must sign institutional review board (IRB) approved consent form indicating such understanding.
- Individuals at least 18 years of age.
- Patients must have histologically or cytologically confirmed prostate cancer.
- Patients must be clinically deemed appropriate for standard of care Lu-177 PSMA RPT.
- Eastern Cooperative Oncology Group (ECOG) performance 0-2
- Patients must be able to comply with all study procedures, including having both the ability and willingness to lie flat for ≥ 30 minutes during imaging.
Exclusion Criteria:
- Patients receiving any concurrent therapy known to impact bone marrow (either stimulate or suppress the marrow, for example G-CSF).
- Patients treated with chemotherapy or 223Ra radiotherapy within 4 weeks.
- All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (CTCAE).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements per treating physician discretion.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Participants scheduled to receive 177Lu-PSMA
Males aged 18 years and older with metastatic PSMA-positive castration-resistant prostate cancer (CRPC) who are scheduled to receive 177Lu-PSMA (PLUVICTO®). Within 7 days prior to 177Lu-PSMA RPT, participants will receive an injection of FLT and then undergo a FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. Whole-body single photon emission computed tomography (SPECT/CT) imaging (2-3 bed positions) will be performed per standard of care on Day 0 (3 +/- 2 h), Day 1 (24 +/- 4 h), and Day 4 (96 +/- 24 h) post-177Lu-PSMA RPT infusion. As standard of care, participants will receive up to 6 infusions of 177Lu-PSMA RPT every 6 weeks at UW Health. |
Within 29 days prior to 177Lu-PSMA RPT, participants will undergo 18F-FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. This is expected to last 2-3 hours. FLT injections will be administered one hour before imaging for tracer uptake. Participants will receive an IV injection of up to 10 mCi (370 MBq) of 18F-FLT. The patient will receive 1 CSE-MRI/FLT PET scan prior to the start of therapy.
Outros nomes:
Within 29 days prior to 177Lu-PSMA RPT, participants will undergo 18F-FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. This is expected to last 2-3 hours. The patient will receive 1 CSE-MRI/FLT PET scan prior to the start of therapy. Up to 3 CSE-MRI scans will be completed as part of this study. At the physician's discretion, a single standard of care (SOC) mid-treatment PSMA PET/MRI can be performed any time during cycles 2-4, and a SOC post-treatment can be done within 6 months of final treatment. CSE-MRI will be acquired during these scans.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Dice similarity coefficient (DSC)
Prazo: up to 14 months
|
The mean Dice similarity coefficient (DSC) between active bone marrow volumes derived from CSE-MRI and ¹⁸F-FLT PET across all enrolled patients.
A mean DSC of ≥0.7 will indicate that CSE-MRI is a clinically acceptable alternative to FLT PET for identifying ABM
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up to 14 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Difference in Mean Tumor Absorbed Dose (Gy)
Prazo: up to 14 months
|
Difference in mean tumor absorbed dose (Gy) across three lesion-segmentation methods, with segmentation performance characterized by DSC relative to physician manual contours.
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up to 14 months
|
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Variance in Tumor and Bone Marrow Volume
Prazo: up to 14 months
|
Repeatability will be measured by variance in tumor and bone marrow volumes.
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up to 14 months
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Variance in Tumor and Bone Marrow Doses
Prazo: up to 14 months
|
Repeatability will be measured by variance in tumor and bone marrow doses
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up to 14 months
|
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Difference in Mean Absorbed Dose (Gy)
Prazo: up to 14 months
|
Difference in mean absorbed dose (Gy) between conventional and CSE-MRI-based ABM dosimetry methods
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up to 14 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael Lawless, PhD, UW School of Medicine and Public Health
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- 2026-0693
- Protocol Version (Outro identificador: UW Madison)
- SMPH / Human Oncology (Outro identificador: UW Madison)
- UW26012 (Identificador de registro: OnCore ID)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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