Image

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

Recruiting
18 - 75 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Study details

Multiple Myeloma

NCT04349358

Centre Georges Francois Leclerc

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.