[68GA] GA-PENTIXAFOR (CXCR4) vs 표준 치료 (SOC)를 사용한 PET/MR 스캔 다발성 골수종 (MM)에서의 후속 조치를위한 표준 치료 (SOC)
[68GA] GA-PENTIXAFOR (CXCR4) PET/MITOUTH 골수종에서의 초기 병기 및 후속 조치에 대한 PET/MR : 표준 치료 PET/CT와의 전향 적 비교 및 치료 영향 평가
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Patrick Veit-Haibach, MD
- 전화번호: 416-340-4800 Ext. 6085
- 이메일: Patrick.Veit-Haibach@uhn.ca
연구 연락처 백업
- 이름: Vishal Kukreti, MD
- 이메일: vishal.kukreti@uhn.ca
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G 2N2
- 모병
- University Health Network
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria
- 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
Exclusion criteria
- 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)
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 |
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실험적: CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging
This arm involves patients undergoing the investigational imaging modality, CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR, to evaluate its diagnostic, prognostic, and therapeutic value in comparison to standard imaging methods. |
[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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic Accuracy of CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging Compared to Standard of Care Imaging
기간: Baseline (at initial staging)
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This primary outcome will assess the diagnostic accuracy of the CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR imaging in comparison to the standard 18F-FDG PET/CT and MRI imaging in newly diagnosed multiple myeloma (MM) patients. Specifically, the focus will be on the number of bone marrow myeloma manifestations detected by CXCR4 PET/MR compared to standard imaging, as well as the number of extra-osseous myeloma manifestations detected. |
Baseline (at initial staging)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evaluating the Role of CXCR4-targeted Imaging in Treatment Decision Making Using a Questionnaire
기간: Post-initial staging (before starting treatment)
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Using a questionnaire, the investigators aim to evaluate how hematologists make treatment decisions based on the addition of CXCR4 PET/MR imaging influences in MM patients, including adjustments in preconditioning, evaluation for radiotherapy, decisions for or against stem cell transplantation, and changes in follow-up schedules. |
Post-initial staging (before starting treatment)
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Evaluating the Role of CXCR4-targeted Imaging in Response Assessment Using a Questionnaire
기간: 3 months after start of participants therapy for MM
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Using a questionnaire, the investigators aim to evaluate how hematologist assess how the availability of CXCR4 PET/MR affects decisions during therapy response assessment. This could include changes in imaging follow-up, supportive therapy decisions, or additional evaluations. |
3 months after start of participants therapy for MM
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Gather data to inform on patient selection for theranostics studies
기간: Baseline (initial staging)
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The investigators will collect all data measurements on imaging and disease characteristics from CXCR4 imaging and standard-of-care imaging, integrating these findings to form a comprehensive assessment of whether patients may be suitable candidates for theranostic studies |
Baseline (initial staging)
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Monitoring for Adverse Events Related to Radiopharmaceutical Administration
기간: 6 months (from baseline to final follow-up)
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Document any adverse events following the administration of the radiopharmaceutical [68Ga]Ga-PentixaFor during PET/MR imaging, including any potential side effects or safety concerns. |
6 months (from baseline to final follow-up)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Patrick Veit-Haibach, MD, University Health Network, Toronto
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
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