NCT04629326

Brief Summary

The objective of the study is to constrcut a noninvasive approach WL12 PET/CT to detect the PD-L1 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from anti-PD-1/L1 treatment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

November 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

July 20, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

3.3 years

First QC Date

November 10, 2020

Last Update Submit

August 16, 2024

Conditions

Gastrointestinal Tumors

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value（SUV）

    The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT

    2 years

Study Arms (1)

Imaging cohort

EXPERIMENTAL

All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-WL12 PET/CT scans

Other: 68Ga-WL12 PET/CT

Interventions

68Ga-WL12 PET/CTOTHER

WL12, labeled with PET radio-nuclide ( Ga-68 )will be used as a molecular imaging tracer for PET/CT scanning

Imaging cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Aged \>18 years old; ECOG 0 or 1;
  • \. Patients with Gastrointestinal tumors;
  • \. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
  • \. life expectancy \>=12 weeks.

You may not qualify if:

  • \. Significant hepatic or renal dysfunction;
  • \. Is pregnant or ready to pregnant;
  • \. Cannot keep their states for half an hour;
  • \. Refusal to join the clinical study;
  • \. Suffering from claustrophobia or other mental diseases;
  • \. Any other situation that researchers think it is not suitable to participate in the experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDigestive System Diseases

Central Study Contacts

Hua Zhu

CONTACT

010-88196495zhuhuabch@pku.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 16, 2020

Study Start

July 20, 2021

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

August 19, 2024

Record last verified: 2024-08

Locations

CN(1)