NCT06795113

Brief Summary

To develop a novel method for evaluating treatment response in lymphoma by utilizing PET/CT imaging data from patients with high-metabolic lymphoma. This involves comparing end-of-treatment PET (EOT-PET) with interim PET (iPET) results to establish a new response assessment approach. The aim is to contrast this method with the Lugano classification criteria, providing clinicians with more scientific and accurate tools for response evaluation and prognosis prediction.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jun 2013Dec 2029

Study Start

First participant enrolled

June 1, 2013

Completed
11.6 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

16.6 years

First QC Date

January 20, 2025

Last Update Submit

January 24, 2025

Conditions

Lymphoma

Keywords

PET/CTlymphoma18F-FDG

Outcome Measures

Primary Outcomes (1)

  • Optimization of 18F-FDG PET/CT Response Assessment and Prognostic Evaluation Strategies for High-Metabolism Lymphoma

    Optimization of 18F-FDG PET/CT Response Assessment and Prognostic Evaluation Strategies for High-Metabolism Lymphoma

    Before the start of treatment, after 4 cycles of treatment(each cycle is 28 days), and 6-8 weeks after the end of treatment.

Secondary Outcomes (1)

  • Progression-Free Survival

    3 years

Study Arms (2)

Modeling group, 2000 patients

clinicopathologic feature, post-treatment efficacy, extracted from the electronic medical record system: demographic characteristics (gender, age, ethnicity, family history, etc.), laboratory test results (complete blood count, blood biochemistry), nasopharyngoscopy, pathology, and nuclear medicine examination reports (PET/CT, PET/MR, etc.), tumor characteristics (tumor size, tumor invasion status, lymph node involvement, staging), and treatment plans.

Validation group, 2000 patients

clinicopathologic feature, post-treatment efficacy, extracted from the electronic medical record system: demographic characteristics (gender, age, ethnicity, family history, etc.), laboratory test results (complete blood count, blood biochemistry), nasopharyngoscopy, pathology, and nuclear medicine examination reports (PET/CT, PET/MR, etc.), tumor characteristics (tumor size, tumor invasion status, lymph node involvement, staging), and treatment plans.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with high-metabolic lymphoma

You may qualify if:

  • Histopathologically confirmed high-metabolic lymphoma
  • Underwent 18F-FDG PET/CT imaging before, during, and after treatment
  • Treated with a standard first-line therapeutic regimen according to lymphoma treatment guidelines and individualized patient-specific considerations

You may not qualify if:

  • : History of prior antitumor treatment 2: History of other malignancies 3: Incomplete clinical data or imaging records 4: Presence of other concurrent malignant tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Rui Guo

CONTACT

13361860108gr11734@rjh.com.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief Physician

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 27, 2025

Study Start

June 1, 2013

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)