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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-28

Study Completion Date

2023-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastrointestinal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intravenous injection of 68Ga-PMD22

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Intravenous injection of 68Ga-PMD22

Intervention Type DRUG

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

Interventions

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Intravenous injection of 68Ga-PMD22

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

Intervention Type DRUG

Other Intervention Names

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68Ga-PMD22

Eligibility Criteria

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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