Actively Recruiting
PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma: a Prospective, Single-arm Clinical Study
Led by Ruijin Hospital · Updated on 2024-10-26
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Positron Emission Tomography/Magnetic Resonance (PET/MR) imaging to improve staging and treatment evaluation for patients newly diagnosed with NK/T-cell lymphoma, a fast-growing and varied type of lymphoma that often affects the nasal area and other body sites. Current standard imaging methods are separate and can be inconvenient, so this study aims to explore a more accurate way to predict patient outcomes and guide therapy. This prospective, single-arm clinical study involves patients undergoing PET/MR scans within 28 days before starting treatment. Depending on their cancer stage, patients receive follow-up PET/MR scans after specific numbers of treatment cycles to assess mid-term and final treatment effects. After treatment, participants have regular follow-ups every 12 weeks for the first year and every 24 weeks thereafter, including clinical exams and additional imaging, to monitor disease status until progression, death, withdrawal, or study completion. Participants will undergo detailed assessments including PET/MR scans, clinical symptom checks, physical exams, and enhanced CT and MR imaging of affected areas. The study will measure how well PET/MR identifies disease stage and treatment response, aiming to develop a predictive system based on these imaging results. Safety monitoring includes histopathological confirmation if disease progression is suspected, with total involvement lasting up to about four years depending on each participant's course.
CONDITIONS
Brief Title
PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically diagnosed NK/T-cell lymphoma based on the WHO classification 2016
- Age from 14 to 70 years-old
- ECOG performance status score between 0 and 2
- Life expectancy of at least 6 months
- No prior treatment for NK/T-cell lymphoma
- Willingness to follow all research procedures and cooperate fully
- Provided written informed consent
You will not qualify if you...
- Diagnosed with aggressive NK cell leukemia
- Pregnant or lactating women
- Liver or kidney insufficiency
- Presence of implanted functional electronic devices like cardiac pacemakers
- Presence of ferromagnetic implants such as carotid aneurysm clips
- Implanted perfusion devices like insulin pumps
- Inability to cooperate with examinations due to coma, mental illness, or critical illness
- Claustrophobia
- Other uncontrolled medical conditions judged by investigators to affect participation
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days before treatment
Participants receive PET/MR examination within 28 days before treatment for pre-treatment evaluation.
1 visit (in-person)
Duration - From start of treatment up to approximately 6 months
Stage I/II participants receive PET/MR again 21-35 days after 2 and 4 courses of standard treatment for mid-term and final efficacy evaluation. Stage III/IV participants receive PET/MR again 21-35 days after 3 and 6 courses of standard treatment for mid-term and final efficacy evaluation.
2 visits for Stage I/II or 2 visits for Stage III/IV (in-person)
Duration - Up to approximately 4 years
Participants undergo follow-up assessments every 12 weeks for the first year, then every 24 weeks thereafter, including clinical symptoms, physical examinations, enhanced CT scans, and MR imaging until disease progression, death, withdrawal, or study completion.
Regular follow-up visits every 12 weeks for 1 year, then every 24 weeks
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200020
Actively Recruiting
Research Team
W
Weili Zhao
P
Pengpeng Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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