Comparing two imaging techniques for detecting lesions in multiple myeloma patients
18F-Fluorocholine (FCH) Versus 18F-Fluorodesoxyglucose (FDG) PET/CT in Detection of Lesions in Patients With Multiple Myeloma
This study is testing which of two imaging techniques is better at finding lesions in newly diagnosed multiple myeloma patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Centre Georges Francois Leclerc Academic / other |
| Locations | 3 sites (Besançon and 2 other locations) |
| Trial ID | NCT04349358 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of two different PET/CT imaging tracers, 18F-fluorodeoxyglucose (FDG) and 18F-fluorocholine (FCH), in detecting lesions in patients newly diagnosed with multiple myeloma. The aim is to determine which tracer reveals more hypermetabolic foci of myeloma during the initial assessment. Patients eligible for the study must be between 18 and 75 years old and have just received their diagnosis. The study will involve imaging assessments using both tracers to evaluate their performance in lesion detection.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who have just been diagnosed with multiple myeloma and are eligible for a hematopoietic stem cell autograft.
Not a fit: Patients with conditions such as MGUS, indolent myeloma, or those already undergoing treatment for myeloma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of multiple myeloma lesions, potentially enhancing treatment planning and patient outcomes.
How similar studies have performed: Other studies have shown promising results with similar imaging approaches, suggesting that this comparison could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Besançon and 2 other locations
- CHU de Besançon — Besançon, France (Recruiting)
- Centre Georges François Leclerc — Dijon, France (Recruiting)
- CHU de Dijon — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Emilie REDERSTORFF
- Email: erederstorff@cgfl.fr
- Phone: 03 43 34 81 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.