PET Imaging Targeting Granzyme B Predicts Immunotherapy E... | NCT06755775

Studies
PET Imaging Targeting Granzyme B Predicts Immunotherapy Efficacy in Diffuse Large B-cell Lymphoma

NCT06755775

Sponsor

Ruijin Hospital

Status

Recruiting

Last Update Posted

Jan 1, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Diffuse Large B-Cell Lymphoma

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 23, 2024Actual

Primary Completion Date

Jul 23, 2029Estimated

Completion Date

Jul 23, 2029Estimated

First Submitted Date

Dec 17, 2024

First Submission Date that Met QC Criteria

Dec 30, 2024

First Posted Date

Jan 1, 2025Actual

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

Dec 30, 2024

Last Update Posted Date

Jan 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate the predictive value of PET imaging targeting granzyme B on the outcome of patients with diffuse large B lymphoma receiving immunotherapy.

Detailed Description

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo 68Ga-grazytracer PET at baseline and after one course of immunotherapy (CAR-T, Glofitamab or iR2 ).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
patients diagnosed with DLBCL who will receive immunotherapy (CAR-T, glofitamab, iR2)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma	The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma	Baseline and 2 weeks after treatment
Standardized uptake value (SUV)	SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions	Baseline and 2 weeks after treatment

Secondary Outcomes

Measure	Description	Time Frame
Progress free suivival	Progress free suivival	3 years
Overall survival	Overall survival	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologic diagnosis of DLBCL
Patient's general condition is good and survival is expected to be greater than six months
Signed and dated informed consent form

Exclusion Criteria:

Combined with other malignant tumors
Patients with serious medical conditions who, in the opinion of the investigator, are not suitable for participation in this clinical study
Pregnant women and women at risk of pregnancy, breastfeeding women
poor compliant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Chinese patient with pathologically confirmed diffuse large B-cell lymphoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xinyi Zhu	Contact	19121913585		zxy16zz@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School	Recruiting	Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse
D052497	Lipodystrophy, Congenital Generalized

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided