Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma
NCT ID: NCT04561492
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2021-09-21
2030-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[68Ga]Ga-PentixaFor
[68Ga]Ga-PentixaFor
Tomography by emission of positons (PET) with theradiopharmaceutic \[68Ga\]Ga-PentixaFor
Interventions
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[68Ga]Ga-PentixaFor
Tomography by emission of positons (PET) with theradiopharmaceutic \[68Ga\]Ga-PentixaFor
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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CHU Bordeaux
Bordeaux, , France
CHU Lille
Lille, , France
HCL
Lyon, , France
Nantes UH
Nantes, , France
APHP - Site Tenon
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-516752-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
RC19_0289
Identifier Type: -
Identifier Source: org_study_id
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