NCT05937919

Brief Summary

To investigate the ability of the CLDN18.2-targeted 68Ga-PMD22 tracer to detect CLDN18.2 expression in patients with gastric and colorectal cancer and other gastrointestinal tumours.

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
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started May 2023

Shorter than P25 for early_phase_1

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

Study Start

First participant enrolled

May 28, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

July 10, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 19, 2023

Last Update Submit

June 30, 2023

Conditions

Gastrointestinal Cancer

Keywords

CLDN18.2Gastric CancerColorectal CancerPositron emission tomography

Outcome Measures

Primary Outcomes (2)

  • Dosimetric distribution of radiopharmaceuticals

    Input the 68Ga-PMD22 PET data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software

    2 months

  • Standardized uptake value

    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured. SUV were obtained by a self-made software and referring to phantom study.If the SUV value cannot be obtained, the COUNTS of target organ/background ratio between the lesion and surrounding tissues shall be used for calculation.

    2 months

Secondary Outcomes (1)

  • Number of participants with drug-related adverse events

    1 month

Study Arms (2)

68Ga-PMD22 PET/CT dynamic scan

EXPERIMENTAL

68Ga-PMD22 PET/CT scan Dosimetry study about 6 patients were injected with 2-4 (MBq) per kilogram body weight of 68Ga-PMD22 PET/CT in one dose intravenously and underwent wholebody scan at 5min#15min#30min#60min#90min#120min#180min, then analysis of dosimetric distribution of radiopharmaceuticals in human body by HERMES software.

Drug: Intravenous injection of 68Ga-PMD22

68Ga-PMD22 PET/CT scan at one time

EXPERIMENTAL

After the dynamic scan completed, choose an optimal imaging examination time for PET examination of other patients.

Drug: Intravenous injection of 68Ga-PMD22

Interventions

Intravenous injection of 68Ga-PMD22DRUG

68Ga-PMD22 were intravenous injected into the patients before PET/CT scans

Also known as: 68Ga-PMD22
68Ga-PMD22 PET/CT dynamic scan68Ga-PMD22 PET/CT scan at one time

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • In the near future (within 2 months), patients who plan to undergo puncture biopsy or undergo tumor surgical treatment or are clinically highly suspected of cancer (including primary and tumor recurrence and metastasis)
  • Able to understand and voluntarily sign informed consent forms, with good compliance

You may not qualify if:

  • Severe abnormalities in liver and kidney function
  • Suffering from claustrophobia or other mental illnesses
  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, China

RECRUITING

Related Publications (1)

  • Wang R, Bai Z, Zhong W, Li C, Wang J, Xiang J, Du J, Jia B, Zhu Z. Synthesis, preclinical evaluation and pilot clinical translation of [68Ga]Ga-PMD22, a novel nanobody PET probe targeting CLDN18.2 of gastrointestinal cancer. Eur J Nucl Med Mol Imaging. 2024 Oct;51(12):3731-3743. doi: 10.1007/s00259-024-06808-5. Epub 2024 Jun 27.

    PMID: 38926162DERIVED

MeSH Terms

Conditions

Gastrointestinal NeoplasmsStomach NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Zhaohui Zhu

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Rongxi Wang

CONTACT

+8615584172170zhzwrx.123@163.com

Zhaohui Zhu

CONTACT

+8619800370331pumch_jacobwong@163.com

Study Design

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

Study Record Dates

First Submitted

June 19, 2023

First Posted

July 10, 2023

Study Start

May 28, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

July 10, 2023

Record last verified: 2023-06

Locations

CN(1)