NCT04883970

Brief Summary

The objective of the study is to constrcut a noninvasive approach 124I-18B10(10L) PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from CLDN18.2 targeting treatment.

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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

May 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

May 13, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

May 7, 2021

Last Update Submit

January 23, 2024

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value（SUV）

    2 years

Study Arms (1)

Imaging cohort

EXPERIMENTAL

All study participants will be allocated to this arm (single-arm study). Study participants will undergo 124I-18B10(10L) PET/CT scans

Other: 124I-18B10(10L) PET/CT

Interventions

124I-18B10(10L) PET/CTOTHER

Study participants will undergo 124I-18B10(10L) PET/CT scans

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)

HUA ZHU

Beijing, China

Location

Related Publications (1)

  • Wang S, Qi C, Ding J, Li D, Zhang M, Ji C, Jiang F, Teng F, Yu J, Qian X, Wang F, Shen L, Gao J, Yang Z, Zhang C, Zhu H. First-in-human CLDN18.2 functional diagnostic pet imaging of digestive system neoplasms enables whole-body target mapping and lesion detection. Eur J Nucl Med Mol Imaging. 2023 Jul;50(9):2802-2817. doi: 10.1007/s00259-023-06234-z. Epub 2023 Apr 26.

    PMID: 37099132DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Hua Zhu

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

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

May 7, 2021

First Posted

May 12, 2021

Study Start

May 13, 2021

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Locations

CN(1)