NCT07597772

Brief Summary

68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for pancreatic cancer

Trial Health

77
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1 pancreatic-cancer

Timeline
1mo left

Started Oct 2025

Shorter than P25 for early_phase_1 pancreatic-cancer

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 Progress86%
Oct 2025Jul 2026

Study Start

First participant enrolled

October 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 19, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 21, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Pancreatic cancer68GaClaudin 18.2

Outcome Measures

Primary Outcomes (4)

  • The safety and tolerability profile of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.

    Occurrence of AE/SAE according to CTCAE 5.0

    1 week

  • CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.

    SUVmax of tumors

    1 week

  • CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.

    SUVmean of tumors

    1 week

  • CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.

    Correlation of tumor uptakes and Immunohistochemistry

    1 week

Study Arms (1)

Group

EXPERIMENTAL

68Ga-NODAGA-SNA006

Drug: 68Ga-NODAGA-SNA006

Interventions

Administration

Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 75 years (inclusive);
  • Possessing legal capacity, voluntarily participating in this clinical trial, and having signed the informed consent form (ICF);
  • Patients with a confirmed diagnosis of pancreatic cancer whose tumours are suitable for Claudin-18.2 testing;
  • Results of gastroscopy, CT, MRI or PET-CT scans performed within the past month (if available);
  • Pathology test results from within the past year;

You may not qualify if:

  • Patients with other clearly diagnosed malignant tumours;
  • Patients with uncontrolled severe infections, or those with other serious comorbidities;
  • Patients with a life expectancy of ≤3 months;
  • Pregnant or breastfeeding patients, and patients of childbearing potential who refuse to use appropriate contraception during the trial;
  • Patients deemed unsuitable for participation in this study by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Dong Dai, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 19, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 19, 2026

Record last verified: 2026-04

Locations