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FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM) (MIM)

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FDG and FCH PET/CT
Sponsored by
Centre Georges Francois Leclerc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring PET/CT, FDG, Fluorocholine (18F) FCH

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de BesançonRecruiting
  • Centre Georges François LeclercRecruiting
  • CHU de DijonRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FDG and FCH PET/CT

Arm Description

Outcomes

Primary Outcome Measures

number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment
PET/CT

Secondary Outcome Measures

Full Information

First Posted
April 10, 2020
Last Updated
October 16, 2023
Sponsor
Centre Georges Francois Leclerc
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1. Study Identification

Unique Protocol Identification Number
NCT04349358
Brief Title
FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)
Acronym
MIM
Official Title
18F-Fluorocholine (FCH) Versus 18F-Fluorodesoxyglucose (FDG) PET/CT in Detection of Lesions in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
PET/CT, FDG, Fluorocholine (18F) FCH

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FDG and FCH PET/CT
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
FDG and FCH PET/CT
Intervention Description
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
Primary Outcome Measure Information:
Title
number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment
Description
PET/CT
Time Frame
before maintenance treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie REDERSTORFF
Phone
03 43 34 81 16
Email
erederstorff@cgfl.fr
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean FONTAN
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clement DROUET
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis CAILLOT

12. IPD Sharing Statement

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FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)

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