68Ga-BCMA PET/CT in Multiple Myeloma

Официальное название

A Prospective, Multicenter, Diagnostic Study Evaluating 68Ga-BCMA PET/CT for Targeting BCMA Expression in Multiple Myeloma.

Обзор

This is a prospective, multicenter diagnostic imaging study designed to evaluate the diagnostic accuracy and clinical utility of BCMA-targeted positron emission tomography/computed tomography (PET/CT) in patients with multiple myeloma and related plasma cell disorders. The study aims to non-invasively visualize and quantify whole-body BCMA expression and to assess its role in the detection of active disease and disease heterogeneity.

Подробное описание

This study is a prospective, multicenter diagnostic imaging investigation designed to evaluate the clinical value of BCMA-targeted positron emission tomography/computed tomography (PET/CT) in patients with multiple myeloma and related plasma cell disorders across different disease states.

Participants will undergo 68Ga-labeled BCMA PET/CT imaging in accordance with a standardized imaging protocol. Imaging findings will be assessed for the presence, distribution, and intensity of BCMA expression at both lesion-based and patient-based levels. Where clinically feasible, imaging findings will be correlated with histopathologic confirmation obtained from biopsy, which will serve as the reference standard for evaluation of diagnostic accuracy.

In addition to lesion detection, this study will explore the relationship between BCMA PET/CT findings and established clinical, laboratory, and imaging parameters. These include conventional imaging modalities, indicators of disease burden, and minimal residual disease (MRD) assessments when available. Longitudinal clinical follow-up will be conducted to assess changes in imaging findings over time and their association with treatment response and disease status.

In a subset of participants, circulating soluble BCMA (sBCMA) levels will be measured in peripheral blood samples collected within a predefined time window around the time of PET/CT imaging. Exploratory analyses will be performed to evaluate the association between sBCMA levels, imaging-derived measures of BCMA expression, and other indicators of disease burden. These analyses are intended to provide complementary biological context for imaging findings and to explore the potential role of integrating imaging and blood-based biomarkers in the assessment of multiple myeloma.

By integrating advanced molecular imaging with clinical, pathological, and biological data, this study aims to characterize whole-body disease burden and heterogeneity in a non-invasive manner and to define the potential clinical utility of BCMA PET/CT for diagnosis, response assessment, and disease monitoring in multiple myeloma.

Вмешательства

• Диагностический тест 68Ga-BCMA PET/CT
  Intravenous administration of the investigational BCMA-targeted radiopharmaceutical, followed by a whole-body PET/CT scan performed per a standardized protocol.

Первичные конечные точки

• Diagnostic performance of 68Ga-BCMA PET/CT [Срок оценки: From enrollment to the end of PET/CT at 4 weeks]
• Safety of BCMA-targeted radiotracer [Срок оценки: Up to 30 days after tracer injection.]

Вторичные конечные точки (3)

• Correlation Between Lesion uptake on BCMA PET/CT and Disease Burden Markers [Срок оценки: Within 2 weeks of PET/CT imaging]
• Detection of extramedullary disease [Срок оценки: Baseline imaging assessment.]
• Impact on clinical management [Срок оценки: Within 30 days after imaging.]

Критерии участия

Критерии включения

• patients with suspected or previously diagnosed multiple myeloma (MM) who were scheduled for bone marrow aspiration or tissue biopsy within two weeks, including those undergoing initial diagnostic evaluation or follow-up/re-evaluation for disease monitoring or relapse;
• patients with confirmed symptomatic MM;
• ability to understand and voluntarily sign written informed consent;
• ability to comply with study procedures;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

Критерии исключения

• pregnancy or lactation;
• inability to comprehend study procedures or cooperate with protocol requirements;
• any other condition judged by the investigator to potentially interfere with study participation.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 5 центров

• Beijing An Zhen Hospital of the Capital University of Medical Sciences — Пекин
• Beijing Tsinghua Changgung Hospital — Пекин
• Peking University First Hospital — Пекин
• the Second Hospital of Hebei Medical University — Shijiazhuang
• First Hospital of Jilin University — Jilin City

Публикации

• Song L, Jiang S, Yang Q, Huang W, Qiu Y, Chen Z, Sun X, Wang T, Wu S, Chen Y, Zeng H, Wang Z, Kang L. Development of a Novel Peptide-Based PET Tracer [68Ga]Ga-DOTA-BP1 for BCMA Detection in Multiple Myeloma. J Med Chem. 2024 Sep 12;67(17):15118-15130. doi: 10.1021/acs.jmedchem.4c00759. Epub 2024 Aug 21. PMID 39167092
• Wang T, Yang Q, Huang W, Sun X, Lei Y, Xu H, Song L, Duan X, Liu F, Wang W, Bao Z, Gao J, Wang F, Kang L. Development and Preclinical Validation of a Novel 89Zr-Labeled BCMA-Targeting Antibody for ImmunoPET Imaging: Application in Multiple Myeloma Models and First-In-Nonhuman-Primates. J Med Chem. 2025 Jul 24;68(14):14843-14858. doi: 10.1021/acs.jmedchem.5c01010. Epub 2025 Jun 25. PMID 40558019
• Gu T, Chen Z, Wang T, Dong Y, Kang L. B-cell maturation antigen targeted PET/CT imaging in multiple myeloma: a first-in-human study. J Hematol Oncol. 2025 Nov 14;18(1):101. doi: 10.1186/s13045-025-01758-3. PMID 41239440

Идентификаторы

NCT: NCT07319897 · PFBC01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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