Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04349358

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

Led by Centre Georges Francois Leclerc · Updated on 2023-10-17

38

Participants Needed

3

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 63 18 and < 75 years
  • Effective contraception for women
  • Informed consent signed
  • Patient able to lie flat for 30 minutes
  • Patient affiliated to a social security scheme
Not Eligible

You will not qualify if you...

  • Diagnosis of MGUS, indolent myeloma (smoldering myeloma), non-secreting myeloma, or recurrent myeloma
  • Already under treatment for myeloma
  • Not eligible for intensive treatment followed by a HSC autograft
  • Presence of concomitant neoplasia
  • History of hematological or solid neoplasia except basal cell carcinoma or adenocarcinoma in situ of uterine cervix
  • History of sarcoidosis
  • Uncontrolled diabetes
  • Treatment with long-term corticosteroids
  • Treatment with hematopoietic growth factors
  • Patient in sepsis
  • Claustrophobia
  • Refusal of patient consent
  • Pregnant or lactating woman
  • Women of childbearing potential without effective contraception
  • Person deprived of liberty or under guardianship
  • Inability to follow medical follow-up due to geographic, social, or psychological reasons
  • History of allergic reaction to 18F-fluorodeoxyglucose or 18F-fluorocholine

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

CHU de Besançon

Besançon, France, 25000

Actively Recruiting

2

Centre Georges François Leclerc

Dijon, France, 21000

Actively Recruiting

3

CHU de Dijon

Dijon, France, 21000

Actively Recruiting

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Research Team

E

Emilie REDERSTORFF

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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