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

Multiple Myeloma Clinical Trial

— MIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04349358
• Other study ID #: 2019-003627-38
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: December 15, 2030

Study information

• Verified date: October 2023
• Source: Centre Georges Francois Leclerc
• Contact: Emilie REDERSTORFF
• Phone: 03 43 34 81 16
• Email: erederstorff[@]cgfl.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 15, 2030
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• FDG and FCH PET/CT
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

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	Centre Georges François Leclerc	Dijon
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment	PET/CT	before maintenance treatment