68Ga-PMD22 PET/CT Examination Targeting CLDN18.2

June 30, 2023 updated by: Peking Union Medical College Hospital

CLDN18.2 Targeted 68Ga-PMD22 PET Imaging in Patients With Gastrointestinal Tumours

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The 2016 FAST study brought a "new star" target for gastric cancer - CLDN18.2 (claudin 18 splice variant 2,CLDN18.2), which belongs to the CLDN family of tight junction proteins and is involved in the formation of paracellular tight junctions and maintenance of cell polarity. CLDN18.2 is mainly found in the normal gastric mucosa (normal gastric glands, principal cells, mural cells, endocrine cells) where the differentiation cycle is short and renewal is rapid, and in the duodenal panniculocytes, but not in the gastric stem cell region. It is now generally accepted that CLDN18.2 is expressed in normal gastric tissue confined to the tight junctions at the outer base of the gastric mucosal cells, whereas tumours undergo a change in cell polarity during malignant transformation, resulting in widespread exposure of CLDN18.2 to the cell membrane surface. The CLDN18.2 gene is also aberrantly activated and highly specific and stably expressed in specific tumour tissues, participating in the proliferation, differentiation and migration of tumour cells, making it a potentially effective target for anti-tumour drugs.

In this study, a molecular probe PMD22 targeting CLDN18.2 was synthesised in a previous study and a 68Ga-PMD22 injection was developed for clinical trials. The preliminary study showed that the tracer has good safety and good imaging effect. It is proposed to further conduct exploratory PET/CT imaging studies on patients with gastric cancer, colorectal cancer and other gastrointestinal tumours, to provide a new technique for in vivo, non-invasive and visual detection of CLDN18.2 expression level and spatial distribution for patients with gastric cancer, colorectal cancer and other gastrointestinal tumours, and to validate its clinical application value for the diagnosis of gastric cancer, colorectal cancer and other gastrointestinal tumours.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-PMD22 PET/CT dynamic scan
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 were intravenous injected into the patients before PET/CT scans
Other Names:
  • 68Ga-PMD22
Experimental: 68Ga-PMD22 PET/CT scan at one time
After the dynamic scan completed, choose an optimal imaging examination time for PET examination of other patients.
Drug: Intravenous injection of 68Ga-PMD22
68Ga-PMD22 were intravenous injected into the patients before PET/CT scans
Other Names:
  • 68Ga-PMD22

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetric distribution of radiopharmaceuticals
Time Frame: 2 months
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
Time Frame: 2 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with drug-related adverse events
Time Frame: 1 month
Adverse events within 1 week after the injection and scanning of patients and patients will be followed by phone call and assessed the safety of 68Ga-PMD22, including blood pressure, blood function, liver and kidney function data, gastrointestinal reactions.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Zhaohui Zhu, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2023

Primary Completion (Estimated)

August 31, 2023

Study Completion (Estimated)

August 31, 2023

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-PMD22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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