Predictive Value of Tumor Microenvironment PET/CT for Response and Prognosis in Aggressive Lympho… (NCT07657494) | Clinical Trial Compass
RecruitingNot Applicable
Predictive Value of Tumor Microenvironment PET/CT for Response and Prognosis in Aggressive Lymphoma: A Multicenter Study
China94 participantsStarted 2024-07-11
Plain-language summary
This multicenter study aims to evaluate the predictive value of tumor microenvironment PET/CT imaging for treatment response and prognosis in patients with aggressive lymphoma. Eligible patients with histologically confirmed aggressive lymphoma will undergo FAPI PET/CT imaging, and selected patients who are candidates for immunotherapy will undergo Grazytracer PET/CT imaging. These imaging methods are intended to assess fibroblast activation protein expression and granzyme B activity in lymphoma lesions, reflecting cancer-associated fibroblasts and cytotoxic T-cell activity in the tumor microenvironment. The study will explore optimal imaging assessment criteria and develop clinical-pathological-imaging models to predict treatment response, prognosis, and the relationship between tumor heterogeneity and refractory or relapsed disease.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed aggressive lymphoma.
* Baseline PET/CT showing moderate to high FDG uptake in lymphoma lesions.
* No previous history of malignant tumors.
* No significant cardiac, hepatic, or renal dysfunction.
* Expected survival of at least 6 months and ability to complete follow-up.
Exclusion Criteria:
* Low FDG uptake on baseline PET/CT.
* Lymphoma lesions have been surgically removed, with no positive lesions available for evaluation.
* Active or uncontrolled chronic inflammation or infection.
* Uncontrolled diabetes mellitus.
* Incomplete clinical data or loss to follow-up.
* Refusal to sign the informed consent form.
* Inability to lie supine for 30 minutes.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive Performance of FAPI PET/CT for Treatment Response or Disease Progression
Timeframe: Every 3 months after enrollment for up to 2 years
Trial details
NCT IDNCT07657494
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences