NCT05004961

Brief Summary

Investigating the performance of Multi-tracer Multimodality PET in lymphoma

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 15, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

3.9 years

First QC Date

August 7, 2021

Last Update Submit

March 2, 2023

Conditions

Positron-Emission Tomography

Keywords

Positron-Emission TomographyLymphoma

Outcome Measures

Primary Outcomes (1)

  • SUVmax

    Standardized uptake value of 68Ga/ 18F-NOTA-FAPI 04 for target lesion of subject or suspected tumor in each time point window (SUV)

    150 days

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients pathologically diagnosed as lymphoma

You may qualify if:

  • pathologically diagnosed as lymphoma;
  • Written informed consent for receiving FAPI-04 PET examinations.
  • cancer planned chemotherapy or immunotherapy scheme.
  • expected survival ≥ 12 weeks

You may not qualify if:

  • cannot lie supine for half an hour;
  • refuse to join the clinical researcher;
  • severe liver or kidney dysfunction
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (1)

  • Chen X, Yuan T, Wei M, Yu B, Zhou N, Zhu H, Yang Z, Wang X. Diagnostic performance of integrated whole-body 18F-FDG PET/MRI for detecting bone marrow involvement in indolent lymphoma: Comparison with 18F-FDG PET or MRI alone. Front Oncol. 2023 Mar 13;13:1136687. doi: 10.3389/fonc.2023.1136687. eCollection 2023.

    PMID: 36994205DERIVED

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yang Zhi, PhD

    Peking University Cancer Hospital & Institute

    STUDY DIRECTOR

Central Study Contacts

Xuejuan Wang, MD

CONTACT

86 010 88196363xuejuan_wang@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2021

First Posted

August 13, 2021

Study Start

September 15, 2019

Primary Completion

August 15, 2023

Study Completion

December 31, 2023

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)