PET/MR Scan With [68Ga]Ga-PentixaFor (CXCR4) vs Standard of Care (SOC) for Initial Staging and Follow up in Multiple Myeloma (MM)

Официальное название

[68Ga]Ga-PentixaFor (CXCR4) PET/MR for Initial Staging and Follow up in Multiple Myeloma: Prospective Comparison With Standard of Care PET/CT and Evaluation of Therapy Influence

Обзор

Multiple myeloma is a disease mainly located in participants bones. Usually a participants physician arrives at this diagnosis by doing blood tests and ordering standard of care imaging tests (18F-FDG PET/CT and maybe additional MRI) to see how many bones (and/or other organs) are affected. While these two imaging tests are already very good, recent research indicates that even more precise imaging methods could be used to diagnose participants disease more precisely. The purpose of this study is to learn if a combined PET/MR scan with a new radiotracer, \[68Ga\]Ga-PentixaFor, can provide more accurate and precise diagnostic information in patients with Multiple Myeloma, a type of cancer primarily affecting the bones. This study aims to improve the accuracy of diagnosing and monitoring Multiple Myeloma using more advanced imaging techniques.

Подробное описание

The investigators will be focusing on Multiple Myeloma patients, a disease mainly located in the participants bones. The goal of this clinical trial is to evaluate the diagnostic and prognostic value of CXCR4-targeted PET/MR imaging in patients with Multiple Myeloma (MM), comparing it to the standard 18F-FDG-PET/CT and MRI imaging for the initial staging, follow-up, and treatment decision-making. The study will focus on newly diagnosed MM patients and those who may undergo stem cell transplantation.

The investigators will compare the performance of \[68Ga\]Ga-PentixaFor PET/MR to standard imaging methods (18F-FDG-PET/CT and MRI) to see if CXCR4-targeted imaging offers improved accuracy, better tumor detection, and a greater influence on treatment decisions.

This study aims to establish whether combining CXCR4-targeted PET/MR imaging could become a comprehensive diagnostic tool for MM, enhancing disease monitoring, guiding therapeutic decisions, and reducing patient burden by eliminating the need for multiple imaging sessions.

Вмешательства

• Препарат [68Ga]Ga-PentixaFor
  \[68Ga\]Ga-PentixaFor will be administered intravenously using the recommended activity for adults which is up to 150 MBq (4 mCi) fixed dose. There is no weight adaption recommended in the literature.

Первичные конечные точки

• Diagnostic Accuracy of CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging Compared to Standard of Care Imaging [Срок оценки: Baseline (at initial staging)]

Вторичные конечные точки (4)

• Evaluating the Role of CXCR4-targeted Imaging in Treatment Decision Making Using a Questionnaire [Срок оценки: Post-initial staging (before starting treatment)]
• Evaluating the Role of CXCR4-targeted Imaging in Response Assessment Using a Questionnaire [Срок оценки: 3 months after start of participants therapy for MM]
• Gather data to inform on patient selection for theranostics studies [Срок оценки: Baseline (initial staging)]
• Monitoring for Adverse Events Related to Radiopharmaceutical Administration [Срок оценки: 6 months (from baseline to final follow-up)]

Критерии участия

Критерии включения

• Patient older than 18 years of age
• Clinical diagnosis of (nonsecretory, oligosecretory, suspicion for extramedullary MM) MM. MM diagnosis is based on IMWG (International Myeloma Working Group) criteria.No treatment received beyond first course of

Критерии исключения

• Any contra-indications for MRI or 18F-FDG PET/CT imaging according to institutional guideline
• Pregnancy (will be ruled out as per institutional protocol)
• Inability to lie still in prone position in MRI for at least 30 min or PET/CT for at least 30 min
• Patients or unwilling to use contraception during study and breastfeeding women can also not partake in this study
• Inability to provide consent
• Any hypersensitivity or known allergy to any component of the investigational product (\[68Ga\]Ga-PentixaFor)No concomitant other malignant hemato-oncological disease being diagnosed (i.e. additional lymphoma or leukemia)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Канада · 1 центр

• University Health Network — Toronto

Идентификаторы

NCT: NCT06871176 · 23-5828

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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