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PET-Enabled Dual-Energy CT in Multiple Myeloma

2026년 6월 9일 업데이트: University of California, Davis

PET-enabled Dual-energy CT for Oncological Applications

This pilot study will evaluate a new imaging method called PET-enabled dual-energy CT for measuring bone and soft-tissue composition in bone marrow. The study will enroll adults with multiple myeloma who are scheduled to receive CAR T-cell therapy and healthy adult participants.

All participants will undergo research imaging with dynamic 18F-FDG PET/CT and X-ray dual-energy CT. Participants with multiple myeloma will have imaging before CAR T-cell therapy and again after therapy. Healthy participants will have one imaging visit.

The main goal is to compare bone and soft-tissue fraction measurements from PET-enabled dual-energy CT with measurements from standard X-ray dual-energy CT. The study will also explore whether corrected PET measurements are associated with bone marrow measurable residual disease, treatment response, and CAR T-cell therapy toxicities in participants with multiple myeloma.

This study is not expected to provide direct medical benefit to participants. The information learned may help improve future PET/CT imaging methods for cancer evaluation.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

This is a single-institution, prospective pilot study evaluating PET-enabled dual-energy CT (DECT) for quantitative bone marrow imaging. The study will enroll adults with multiple myeloma who are scheduled to receive CAR T-cell therapy and healthy adult participants for comparison.

PET-enabled DECT is an imaging method that uses data from a standard time-of-flight PET/CT scan to generate a high-energy attenuation image. This image is combined with the standard X-ray CT image to create a dual-energy image pair. The goal is to measure tissue composition, including bone fraction and soft-tissue fraction, without requiring dedicated dual-energy PET/CT hardware.

All participants will undergo research imaging with dynamic 18F-FDG PET/CT and X-ray DECT. Participants with multiple myeloma will undergo baseline imaging before CAR T-cell therapy and follow-up imaging after therapy. Healthy participants will undergo one imaging visit. Multiple myeloma participants will also have bone marrow measurable residual disease (MRD), treatment response, and CAR T-cell therapy toxicity data collected from standard clinical care or related clinical assessments.

The primary objective is to develop and validate the new DECT method for quantitatively measuring tissue compositions of bone marrow regions in multiple myeloma and healthy participants using X-ray DECT as the reference. Secondary objectives include: To determine whether bone fraction in bone marrow differs between MM patients and healthy participants and whether PET-enabled DECT can accurately estimate bone fraction for correcting PET-based bone-marrow metabolic measurements; and, to evaluate relationships between corrected PET measures and bone marrow MRD and treatment response and toxicities of CAR T-cell therapy in MM patients This study is exploratory and is designed to collect preliminary data to support future larger studies. The research imaging is not intended to guide clinical care, and participants are not expected to receive direct medical benefit from participation. The information learned may help improve quantitative PET/CT imaging methods for future cancer evaluation and treatment monitoring.

연구 유형

중재적

등록 (추정된)

45

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • California
      • Sacramento, California, 미국, 95816
        • UC Davis EXPLORER Molecular Imaging Center
        • 수석 연구원:
          • Guobao Wang, PhD
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

For all research participants:

  • Adults (age ≥ 18 years old)
  • Ability to understand and willingness to sign an informed consent form
  • Ability to adhere to the study visit schedule and other protocol requirements.
  • Willing and able to fast for at least 6 hours before and for the duration of the scan
  • No strenuous exercise for 24 hours prior to being scanned
  • Willing to lie on the scanner bed for up to 60 minutes

For healthy volunteers only:

• Free of history of cardiovascular, inflammatory, infections or metabolic diseases that would result in changes in bone marrow.

For cancer patients only:

  • Patients with multiple myeloma who are planned to receive CAR T-cell therapy with any FDA-approved product, including Idecel and Ciltacel. Patients with prior chemo-immunotherapy are permitted.
  • Able to undergo bone marrow aspirate/biopsy procedure

Exclusion Criteria:

  • Self-reported history of dysphoria or anxiety in closed spaces
  • Body weight >240 kg due to limitations of the scanner bed
  • Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test will be administered prior to start of each PET/CT session for all participants between 18 to 60 years old who are able to get pregnant, unless documented hysterectomy or bilateral ovarian removal is available)
  • Blood glucose greater than 200 as assessed by fingerstick method before injection of 18F-FDG
  • Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only. That is, PET scans are not performed as part of a patient's treatment plan (e.g. standard of care, therapeutic purposes, or clinical care) and the research study did not intend to provide therapeutic benefit to the patient.
  • Prisoners
  • Any condition that would prevent the understanding or rendering of informed consent.
  • Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Multiple Myeloma Participants
Adults with multiple myeloma who are scheduled to receive CAR T-cell therapy. Participants will undergo baseline dynamic 18F-FDG PET/CT and X-ray dual-energy CT imaging before CAR T-cell therapy. Participants will also undergo follow-up dynamic 18F-FDG PET/CT and X-ray dual-energy CT imaging after CAR T-cell therapy.
진단 검사: PET-enabled dual-energy CT imaging
18F-FDG will be administered intravenously for dynamic PET/CT imaging.
진단 검사: X-ray dual-energy CT imaging
Participants will undergo X-ray dual-energy CT imaging. Measurements from X-ray dual-energy CT will be used as the reference method for comparison with PET-enabled dual-energy CT measurements.
실험적: Healthy Participants
Healthy adult participants without a history of cardiovascular, inflammatory, infectious, or metabolic diseases expected to affect bone marrow. Participants will undergo one dynamic 18F-FDG PET/CT and X-ray dual-energy CT imaging visit.
진단 검사: PET-enabled dual-energy CT imaging
18F-FDG will be administered intravenously for dynamic PET/CT imaging.
진단 검사: X-ray dual-energy CT imaging
Participants will undergo X-ray dual-energy CT imaging. Measurements from X-ray dual-energy CT will be used as the reference method for comparison with PET-enabled dual-energy CT measurements.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Agreement between PET-enabled DECT and X-ray DECT measurements of bone marrow tissue fractions
기간: Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
Agreement between PET-enabled dual-energy CT and standard X-ray dual-energy CT will be assessed for quantitative bone fraction and soft-tissue fraction measurements in bone marrow regions.
Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation

2차 결과 측정

결과 측정
측정값 설명
기간
Difference in bone marrow bone fraction between multiple myeloma participants and healthy participants
기간: Baseline imaging visit
Bone fraction in bone marrow regions will be compared between participants with multiple myeloma and healthy participants using PET-enabled DECT and X-ray DECT measurements.
Baseline imaging visit
Corrected 18F-FDG standardized uptake value in bone marrow
기간: Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
Bone marrow 18F-FDG standardized uptake value will be corrected for bone fraction using PET-enabled DECT-derived tissue fraction measurements.
Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
Association between corrected PET measures and bone marrow measurable residual disease
기간: Baseline and follow-up assessments through approximately Day +90 after CAR T-cell therapy initiation
Corrected PET measures, including corrected standardized uptake value and kinetic parameters, will be evaluated for association with bone marrow measurable residual disease in multiple myeloma participants.
Baseline and follow-up assessments through approximately Day +90 after CAR T-cell therapy initiation
Association between corrected PET measures and CAR T-cell therapy response and toxicities
기간: Baseline imaging through approximately Day +90 after CAR T-cell therapy initiation
Corrected PET measures, including corrected bone marrow standardized uptake value and 18F-FDG kinetic parameters, will be evaluated for association with CAR T-cell therapy response and toxicities in participants with multiple myeloma.
Baseline imaging through approximately Day +90 after CAR T-cell therapy initiation

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of California, Davis

협력자

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

수사관

  • 수석 연구원: Guobao Wang, PhD, University of California, Davis

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2030년 8월 1일

연구 완료 (추정된)

2030년 11월 1일

연구 등록 날짜

최초 제출

2026년 6월 9일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2399411
  • 1R01EB036562-01 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

다발성 골수종(MM)에 대한 임상 시험

PET-enabled dual-energy CT imaging에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Jordan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다