The Performance of Multi-tracer Multimodality PET in Lymp... | NCT05004961

Studies
The Performance of Multi-tracer Multimodality PET in Lymphoma

NCT05004961

Sponsor

Peking University Cancer Hospital & Institute

Status

Unknown status

Last Update Posted

Mar 3, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Positron-Emission Tomography

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2019Actual

Primary Completion Date

Aug 15, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Aug 7, 2021

First Submission Date that Met QC Criteria

Aug 7, 2021

First Posted Date

Aug 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2023

Last Update Posted Date

Mar 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xuejuan Wang, Principal Investigator, Peking University Cancer Hospital & InstitutePrincipal Investigator

Lead Sponsor

Peking University Cancer Hospital & InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Investigating the performance of Multi-tracer Multimodality PET in lymphoma

Detailed Description

In this study investigators evaluated Nodal and Extranodal Lymphoma Lesions uptake by different molecular probe such as FDG, FAPI-04 via multimodality PET (PET/CT and PET/MR). Our Previous studies have shown that uptake of FAPI-04 on PET may be an indicator of lymphoma lesions. The combination of PET with CT/MR allows for depicting metabolic, functional and morphological properties of tumor lesions at the same time, which is therefore an alternative attractive pairing for diagnosis, staging and prognosis of lymphoma.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

patients pathologically diagnosed as lymphoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xuejuan Wang, MD	Contact	86 010 88196363		xuejuan_wang@hotmail.com

Overall Officials

Name	Affiliation	Role
Yang Zhi, PhD	Peking University Cancer Hospital & Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Cancer Hospital	Recruiting	Beijing	Beijing Municipality	100142	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36994205	Derived	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.

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases