FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)
MIM
18F-Fluorocholine (FCH) Versus 18F-Fluorodesoxyglucose (FDG) PET/CT in Detection of Lesions in Patients With Multiple Myeloma
1 other identifier
interventional
38
1 country
3
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 the most widely used tracer but findings suggest that PET/CT reveal more lesions when using FCH. In this study, FDG is compared with a more recent metabolic tracer, 18F-fluorocholine (FCH), for the detection of multiple myeloma lesions at time of initial extension assessment. The principal objective of this sudy is to compare the number of suspected hypermetabolic foci of myeloma detected by 18F-fluorocholine PET and by 18F-fluorodeoxyglucose PET during the initial extension assessment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-myeloma
Started Dec 2020
Longer than P75 for not_applicable multiple-myeloma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedStudy Start
First participant enrolled
December 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2030
ExpectedOctober 17, 2023
October 1, 2023
2 years
April 10, 2020
October 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment
PET/CT
before maintenance treatment
Study Arms (1)
FDG and FCH PET/CT
OTHERInterventions
* during the initial myeloma check-up : FDG and FCH PET/CT exams (maximum 21 days after inclusion) * just before maintenance treatment, respecting a minimum interval of 2 weeks after the last course of chemotherapy : FDG and FCH PET/CT exams
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CHU de Besançon
Besançon, 25000, France
Centre Georges François Leclerc
Dijon, 21000, France
CHU de Dijon
Dijon, 21000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2020
First Posted
April 16, 2020
Study Start
December 15, 2020
Primary Completion
December 15, 2022
Study Completion (Estimated)
December 15, 2030
Last Updated
October 17, 2023
Record last verified: 2023-10