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[68Ga]Ga-PentixaFor positron emission tomography for improved risk and disease assessment in myeloma
EU CTIS ID: 2022-501811-14-00
What this study is testing
To evaluate the proportion of false negative (FN) PET results for [68Ga]Ga-PentixaFor PET/AC-CT at baseline.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All patients who are eligible to start the IMMPROVED study (and signed for participation) can be included in this exploratory study.
- Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT (Inclusion criteria of the IMMPROVED study). patients can therefore also be included after ASCT, prior to lenalidomide maintenance.
- Baseline 18F-FDG PET/CT scan (Inclusion criteria of the IMMPROVED study)
- WHO performance status 0-2 (WHO > 2 can be allowed if the patient is fit for intensive chemotherapy based on the opinion of the physician). (Inclusion criteria of the IMMPROVED study)
- 18 years of older (Inclusion criteria of the IMMPROVED study)
- Signed informed consent.
You likely can't join if
- Any physical or physiological condition that may affect adherence to the study protocol, e.g severe claustrophobia or the inability to lie still for 30 minutes.
- History of concomitant presence of any other malignancy, except for: non-melanoma skin cancer, carcinoma in situ of the cervix, or any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment.
- Pregnant or breastfeeding
- Refusal or inability to provide written informed consent
See the full eligibility criteria
- All patients who are eligible to start the IMMPROVED study (and signed for participation) can be included in this exploratory study.
- Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT (Inclusion criteria of the IMMPROVED study). patients can therefore also be included after ASCT, prior to lenalidomide maintenance.
- Baseline 18F-FDG PET/CT scan (Inclusion criteria of the IMMPROVED study)
- WHO performance status 0-2 (WHO > 2 can be allowed if the patient is fit for intensive chemotherapy based on the opinion of the physician). (Inclusion criteria of the IMMPROVED study)
- 18 years of older (Inclusion criteria of the IMMPROVED study)
- Signed informed consent.
- Life expectancy > 12 months, based on clinical judgement (Inclusion criteria of the IMMPROVED study)
- Baseline [68Ga]Ga-PentixaFor PET/CT should be scheduled before starting induction chemotherapy. Exception for patients who will be included after ASCT, but prior to lenalidomide maintenance therapy. (Specific for this study).
- An interval of maximum 14 days is allowed between the 18F-FDG and [68Ga]Ga-PentixaFor PET/CT scans (Specific for this study).
- Any physical or physiological condition that may affect adherence to the study protocol, e.g severe claustrophobia or the inability to lie still for 30 minutes.
- History of concomitant presence of any other malignancy, except for: non-melanoma skin cancer, carcinoma in situ of the cervix, or any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment.
- Pregnant or breastfeeding
- Refusal or inability to provide written informed consent
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.