- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04349358
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
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emilie REDERSTORFF
- Phone Number: 03 43 34 81 16
- Email: erederstorff@cgfl.fr
Study Locations
-
-
-
Besançon, France, 25000
- Recruiting
- CHU de Besancon
-
Contact:
- Jean FONTAN
-
Dijon, France, 21000
- Recruiting
- CHU de Dijon
-
Contact:
- Denis CAILLOT
-
Dijon, France, 21000
- Recruiting
- Centre Georges François Leclerc
-
Contact:
- Clement DROUET
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: FDG and FCH PET/CT
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment
Time Frame: before maintenance treatment
|
PET/CT
|
before maintenance treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- 2019-003627-38
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
-
Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on FDG and FCH PET/CT
-
Sir Mortimer B. Davis - Jewish General HospitalCompletedProstate CancerCanada
-
University of UtahNational Cancer Institute (NCI)CompletedFluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) in Cancer Associated VenothromboembolismVenothromboembolismUnited States
-
University of Lausanne HospitalsCompletedProstate CancerSwitzerland
-
Washington University School of MedicineTerminatedCervical Cancer | Uterine Cervical Neoplasms | Uterine Cervical CancerUnited States
-
Region VästerbottenUmeå UniversityRecruitingCervix Cancer | Endometrial Cancer | Epithelial Ovarian CancerSweden
-
Peter MacCallum Cancer Centre, AustraliaMelbourne Health; Westmead Hospital; Victorian Infectious Diseases Reference...CompletedAcute Myeloid Leukemia | Febrile Neutropenia | Acute Lymphoblastic Leukemia | Haematopoietic Stem Cell Transplant, Autologous | Haematopoietic Stem Cell Transplant, AllogeneicAustralia
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedMalignant Neoplasm of Breast TNM Staging Distant Metastasis (M) | Untreated Bone MetastasesUnited States
-
Abramson Cancer Center at Penn MedicineActive, not recruiting
-
University of ZurichWithdrawnAdenocarcinoma | Stomach Cancer | Cancer of Esophagogastric JunctionSwitzerland
-
Rabin Medical CenterUnknown