NCT05436093

Brief Summary

The objective of the study is to construct a noninvasive approach 68Ga-ACN376 PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Jun 2022

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

Study Progress72%
Jun 2022Dec 2027

First Submitted

Initial submission to the registry

June 23, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

June 23, 2022

Last Update Submit

March 2, 2026

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value（SUV）

    SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （68Ga-ACN376） in solid tumor lesions by measuring SUV on PET/CT.

    2 years

Study Arms (1)

68Ga-ACN376

EXPERIMENTAL

Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-ACN376 PET/CT scan.

Drug: 18F-FDG

Interventions

18F-FDGDRUG

All study participants will undergo one 18F-FDG PET/CT scan.

68Ga-ACN376

Eligibility Criteria

Age18 Years - 75 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 solid 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

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Hua Zhu

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Zhu

CONTACT

010-88196495zhuhuabch@pku.edu.cn

Study Design

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

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 28, 2022

Study Start

June 23, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

CN(1)