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NCT Number: NCT05662540

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

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.

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Key information

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

Location status: Recruiting

Location contact

Weili ZHAO

CONTACT

[email protected]

+862164370045 ext. 610707

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Those with implanted functional electronic devices such as cardiac pacemakers
  • Carotid aneurysm clipping and other implants are ferromagnetic materials
  • Implanted perfusion devices such as insulin perfusion pumps
  • Those who do not cooperate in examinations such as coma, mental illness, and critically ill patients
  • Those who are claustrophobic
  • Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study

Treatment and study plan

Positron Emission Tomography/Magnetic Resonance (PET/MR)

Device

18F-FDG PET/MR imaging (manufacturer: Siemens, model: Biography mMR). Research devices are marketed products.

Primary outcomes

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

    Time frame: 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

    Time frame: After at least 2 cycles

    SUVmax, organs, et al.

Secondary outcomes

  1. Exploratory construction of prognostic prediction or efficacy evaluation system for newly treated NK/T-cell lymphoma based on PET/MR imaging indicators.

    Time frame: Baseline up to data cut-off (up to approximately 4 years)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Pengpeng Xu

CONTACT

[email protected]

+862164370045

Weili Zhao

CONTACT

[email protected]

+862164370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma: a Prospective, Single-arm Clinical Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 22, 2022
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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