Exploratory Phase 1 Study of PET Imaging with 18F-Fludarabine for Initial and End-of-Treatment Evaluation in Symptomatic Multiple Myeloma Patients Not Eligible for Bone Marrow Transplant

What this Trial Is About

Researchers are evaluating the use of 18F-Fludarabine PET scans to detect lesions in patients with symptomatic multiple myeloma MM who are not candidates for autologous bone marrow transplantation. This exploratory Phase 1 study aims to compare the sensitivity of 18F-Fludarabine PET to standard imaging methods like FDG-PET and MRI at initial diagnosis and to assess its usefulness at the end of treatment. The study is sponsored by Nantes University Hospital and focuses on patients receiving first-line therapy for MM. Participants will undergo two PET scans using 18F-Fludarabine one before starting treatment and one at the end of their therapy. The study monitors the detection and evaluation of bone and other lesions through these scans. The goal is to investigate the diagnostic value and prognostic impact of 18F-Fludarabine PET compared to existing imaging techniques, including correlations with cytogenetic data and FDG uptake. During the study, researchers will assess the sensitivity, specificity, and predictive values of 18F-Fludarabine PET scans before and after treatment. Patients will have blood tests, pregnancy tests if applicable, and clinical evaluations such as Karnofsky or ECOG performance status assessments. The study includes monitoring for tolerance to 18F-Fludarabine and its correlation with disease markers. Participation duration varies, with imaging and clinical assessments conducted at baseline and treatment completion, followed by safety and outcome evaluations.

Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients