Multiple MyelomaMIMNCT04349358
FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)
A study testing FDG and FCH PET/CT in people with Multiple Myeloma, run by Centre Georges Francois Leclerc at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- FDG and FCH PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Dec 2020to 15 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Jean FONTAN
- Recruiting
Centre Georges François Leclerc
Dijon, 21000
Clement DROUET
- Recruiting
CHU de Dijon
Dijon, 21000
Denis CAILLOT
About this study
Official title: 18F-Fluorocholine (FCH) Versus 18F-Fluorodesoxyglucose (FDG) PET/CT in Detection of Lesions in Patients With Multiple Myeloma
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
- Multiple Myeloma
- Being tested
- FDG and FCH PET/CT
- Keywords
- PET/CT, FDG, Fluorocholine (18F) FCH
- Medical subject headings
- Multiple Myeloma, Nuchal bleb, familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG and FCH PET/CTOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| FDG and FCH PET/CT | Other | Not described Receives: Other: FDG and FCH PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment
PET/CT
Measured: before maintenance treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start15 Dec 2020
- Primary completion15 Dec 2022
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349358
- Sponsor's protocol ID
- 2019-003627-38
- Other IDs
- 2019
- Acronym
- MIM
- Status last verified
- Oct 2023
- First submitted
- 10 Apr 2020
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluorocholine (FCH) Versus 18F-Fluorodesoxyglucose (FDG) PET/CT in Detection of Lesions in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04349358
- Acronym / sponsor ID
- MIM / 2019-003627-38
- Conditions
- Multiple Myeloma
- Keywords
- PET/CT, FDG, Fluorocholine (18F) FCH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG and FCH PET/CT | Other | Other: FDG and FCH PET/CT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | FDG and FCH PET/CT |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG and FCH PET/CT in people with Multiple Myeloma, run by Centre Georges Francois Leclerc at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie REDERSTORFF (03 43 34 81 16, erederstorff@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of hypermetabolic foci of myeloma detected by FCH PET versus by FDG PET during the initial extension assessment (time frame: before maintenance treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.