PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05662540
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 46
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This study intends to evaluate the application value of Positron Emission Tomography/Magnetic Resonance (PET/MR) in the staging and efficacy evaluation of NK/T cell lymphoma, aiming to explore a more accurate system for predicting the prognosis of patients and guiding the treatment.

Condition or Disease	Intervention/Treatment	Phase
NK/T-cell Lymphoma	Device: Positron Emission Tomography/Magnetic Resonance (PET/MR)	N/A

Detailed Description

Nature Killer/T-cell Lymphoma (NKTCL) is a highly heterogeneous, aggressive lymphoma subtype with poor prognosis. Ninty percent of patients have lesions involving the nasal region, other extranodal organs include adrenal glands, gastrointestinal tract, skin and so on. Local tumor infiltration (bone, skin, paranasal sinus, etc) is a poor prognostic factor. Therefore, NK/T-cell lymphomas have high demands on the resolution of fine anatomical structures. PET/CT and nasopharyngeal contrast-enhanced MR are routine examination methods for diagnostic staging and efficacy evaluation, but the images cannot be fused, and the divided examinations bring inconvenience to patients.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma: a Prospective, Single-arm Clinical Study
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2025
• Anticipated Study Completion Date: Oct 1, 2026

Arms and Interventions

Arm

Intervention/Treatment

Experimental: PET/MR This is a prospective, single-arm clinical study. Subjects who meet the inclusion criteria will receive PET/MR examination within 28 days before treatment after signing the informed consent form for pre-treatment evaluation. Stage I/II patients received PET/MR again 21-35 days after 2 and 4 courses of standard treatment for mid-term and final efficacy evaluation. Stage III/IV patients received PET/MR again 21-35 days after 3 and 6 courses of standard treatment for mid-term and final efficacy evaluation. Follow-up assessments are then continued, every 12 weeks for the first year, and every 24 weeks thereafter (clinical symptoms, physical examination, enhanced CT of the cervix, abdomen, and pelvis, and enhanced MR of the nasopharynx) until disease progression (PD), death, withdrawal of informed consent, or study finish. For subjects with suspected PD, histopathological results should be obtained whenever possible to confirm or exclude PD status.

Device: Positron Emission Tomography/Magnetic Resonance (PET/MR); 18F-FDG PET/MR imaging (manufacturer: Siemens, model: Biography mMR). Research devices are marketed products.

Outcome Measures

Primary Outcome Measures

1. The sensitivity, specificity and accuracy of PET/MR in the staging of newly diagnosed NK/T-cell lymphoma patients [Baseline]

   SUVmax, organs, et al.

2. The sensitivity, specificity and accuracy of PET/MR in the efficacy evaluation of newly diagnosed NK/T-cell lymphoma patients [After at least 2 cycles]

   SUVmax, organs, et al.

Secondary Outcome Measures

1. Exploratory construction of prognostic prediction or efficacy evaluation system for newly treated NK/T-cell lymphoma based on PET/MR imaging indicators. [Baseline up to data cut-off (up to approximately 4 years)]

   SUVmax, organs, progression-free survival, overall survival, et al.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pathologically diagnosed NK/T-cell lymphoma based on the WHO classification 2016

• Age from 14 to 70 years-old

• ECOG 0-2 score

• Patients with a life expectancy of at least 6 months

• Patient has not been treated before for NK/T cell lymphoma

• Commit to abide by the research procedures and cooperate with the implementation of the whole process of research

• Written informed consent

Exclusion Criteria:

• Subjects who meet any of the following criteria are not eligible for study entry

• Diagnosed aggressive NK cell leukemia

• Pregnant or lactating women

• Liver and kidney insufficiency

• Other PET/MR contraindications:

1. Those with implanted functional electronic devices such as cardiac pacemakers

2. Carotid aneurysm clipping and other implants are ferromagnetic materials

3. Implanted perfusion devices such as insulin perfusion pumps

4. Those who do not cooperate in examinations such as coma, mental illness, and critically ill patients

5. Those who are claustrophobic

• Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital	Shanghai	Shanghai	China	200020

Sponsors and Collaborators

• Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhao Weili, First Deputy Director, Hematology Department, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT05662540
• Other Study ID Numbers: NK-PETMR
• First Posted: Dec 22, 2022
• Last Update Posted: Dec 22, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Dec 22, 2022