Status:
RECRUITING
FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)
Lead Sponsor:
Centre Georges Francois Leclerc
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Hybrid positron emission tomography/computed tomography (PET/CT) has now become available to detect tumors in patients with multiple myeloma. The radioactive glucose 18F-fluorodeoxyglucose (FDG) is th...
Eligibility Criteria
Inclusion
- Patient with initial diagnosis of multiple myeloma has just been established
- Therapeutic indication and eligible for a HSC autograft (if the HSC autograft could not be performed, the patient will still be retained in the study).
- Status ECOG 0, 1 or 2
- Age ≥ 18 and \< 75 ans years
- Effective contraception for women
- Informed consent signed
- Patient able to lie flat for 30 minutes
- Patient affiliated to a social security scheme
Exclusion
- Patient diagnosed with a diagnosis of MGUS (Monoclonal Gammapathy of Undetermined Significance = monoclonal gammopathy of undetermined significance), indolent myeloma ("smoldering myeloma"), non-secreting myeloma or recurrent myeloma,
- Patient already under treatment for myeloma.
- Patient not eligible for intensive treatment followed by a HSC autograft.
- Patient with concomitant neoplasia
- Patient with a history of hematological or solid neoplasia, except if it is a basal cell carcinoma of the skin or an adenocarcinoma in situ of the uterine cervix.
- Patient with a history of sarcoidosis
- Uncontrolled diabetes.
- Patient treated with long-term corticosteroids
- Patient being treated with hematopoietic growth factors
- Patient in sepsis.
- Claustrophobic patient.
- Refusal of patient consent.
- Pregnant or lactating woman.
- Women of childbearing potential without effective contraception.
- Person deprived of liberty or under guardianship
- Impossibility to submit to the medical follow-up of the trial for geographic, social or psychological reasons.
- History of allergic reaction attributed to 18F-fluorodeoxyglucose or to 18F-fluorocholine.
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2030
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04349358
Start Date
December 15 2020
End Date
December 15 2030
Last Update
October 17 2023
Active Locations (3)
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1
CHU de Besançon
Besançon, France, 25000
2
Centre Georges François Leclerc
Dijon, France, 21000
3
CHU de Dijon
Dijon, France, 21000