Clinical trial · Interventional
Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma
Exploratory Study Evaluating the Relevance of [68Ga]Ga -PentixaFor for Initial Staging and Therapeutic Evaluation of Symptomatic Multiple Myeloma Patients in First Line Treatment or in Relapse
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of our study is to confirm the relevance of PET using \[68Ga\]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and \[68Ga\]Ga -PentixaFor/FDG discordances explored.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-PentixaFor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-PentixaFor
- interventionNames
- Drug: [68Ga]Ga-PentixaFor
Primary outcomes (1)
- measure
- To determine the sensitivity of [68Ga]Ga-PentixaFor-PET to detect Multiple Myeloma (MM) lesions [Bone marrow (BM) lesions and/or extra-medullary disease (EMD) ] at the time of initial diagnosis or at relapse.
- timeFrame
- 1 Month
- description
- Sensitivity will be assessed by patient and lesion analysis by defining: * True positive (TP): * lesion positive with \[68Ga\]Ga-PentixaFor-PET and positive by FDG-PET * or lesion positive with \[68Ga\]Ga-PentixaFor-PET, negative on FDG-PET but confirmed by another CT scan/ MRI or histology, or confirmed by follow-up (until therapeutic evaluation). * False negative (FN): - lesion negative with \[68Ga\]Ga-PentixaFor-PET and positive by FDG-PET and confirmed by CT or MRI or histology, or confirmed by follow-up.
Secondary outcomes (12)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment * Written and signed informed consent (obtained on the screening day at the latest and before any investigation) * ECOG (Eastern Cooperative Oncology Group) \< 2 * Patient affiliated to or beneficiary of the National Health Service Exclusion Criteria: * HIV positive, active Hepatitis B or C * Childbearing or child breast feeding women * Women or men without effective contraceptive barrier if needed * eGFR \< 50 ml/min by MDRD or CKDEPI * Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Known active infection * Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus * Patient under guardianship or trusteeship * Patient under judicial protection
References
Publications (1)
- DERIVEDFrancois C, Carlier T, Touzeau C, Janz A, Dubegny C, Jamet B, Kraeber-Bodere F, Bailly C, Bodet-Milin C. Optimal acquisition time of [68Ga]Ga-PentixaFor PET/CT for initial staging of multiple myeloma: an ancillary study to the PentiMyelo protocol. EJNMMI Res. 2026 Mar 13;16(1):67. doi: 10.1186/s13550-026-01410-2. PMID 41820762