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NCT Number: NCT04349358

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FDG and FCH PET/CT

Other
  • 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 outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie REDERSTORFF

CONTACT

[email protected]

03 43 34 81 16

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study title

18F-Fluorocholine (FCH) Versus 18F-Fluorodesoxyglucose (FDG) PET/CT in Detection of Lesions in Patients With Multiple Myeloma

Acronym: MIM

Important dates

Study start
2020
Primary completion
2022
Study completion
2030
First posted
Apr 16, 2020
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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