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Trial Title:
68Ga-PMD22 PET/CT Examination Targeting CLDN18.2
NCT ID:
NCT05937919
Condition:
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Conditions: Keywords:
CLDN18.2
Gastric Cancer
Colorectal Cancer
Positron emission tomography
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Intravenous injection of 68Ga-PMD22
Description:
68Ga-PMD22 were intravenous injected into the patients before PET/CT scans
Arm group label:
68Ga-PMD22 PET/CT dynamic scan
Arm group label:
68Ga-PMD22 PET/CT scan at one time
Other name:
68Ga-PMD22
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu
Phone:
+8619800370331
Email:
pumch_jacobwong@163.com
Start date:
May 28, 2023
Completion date:
August 31, 2023
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05937919
