Pancreatic CancerNCT07554742
Non-Invasive Detection of claudin18.2 in Pancreatic and Gastric/Gastroesophageal Junction Cancer by [68Ga]Ga-NODAGA-SNA014 PET Imaging
An observational study of Pancreatic Cancer and Gastric Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to use Claudin 18.2 (CLDN18.2)-targeted positron emission tomography (PET) imaging technology to evaluate its detection efficacy and diagnostic threshold for CLDN18.2-positive pancreatic cancer and gastric/gastroesophageal junction cancer, analyze the quantitative value of PET parameters… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Gastric Cancer, Gastroesophageal Junction Cancer
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 31 Mar 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible inpatients and outpatients from Ruijin Hospital
Who may be able to join
- Participants with histopathologically confirmed pancreatic cancer and gastric/gastroesophageal junction cancer with claudin 18.2 expression of any level, including treatment-naive patients with upfront resectable disease, patients with post-operative recurrent disease who are or become resectable following treatment, and patients rendered resectable after neoadjuvant or conversion therapy.
- Signed and dated informed consent form.
- Commitment to comply with research procedures and co-operation in the implementation of the full research process.
- Male or female participants.
- Aged 18-75 years old.
- Good general performance status with an expected overall survival of more than 6 months.
Who cannot join
- Participants with prior Claudin 18.2 targeted therapy.
- Participants with concurrent other active malignancies.
- Participants with severe medical conditions that render them unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
- Pregnant women and women who may be pregnant, women who are breastfeeding.
- Participants with poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Shanghai
Jiajia Hu, 13524945287, jiajiahu@shsmu.edu.cn
About this study
Official title: Non-Invasive Detection of Claudin18.2 in Pancreatic and Gastric/Gastroesophageal Junction Cancer by [68Ga]Ga-NODAGA-SNA014 PET Imaging
The purpose of this study is to use Claudin 18.2 (CLDN18.2)-targeted positron emission tomography (PET) imaging technology to evaluate its detection efficacy and diagnostic threshold for CLDN18.2-positive pancreatic cancer and gastric/gastroesophageal junction cancer, analyze the quantitative value of PET parameters in CLDN18.2 expression and their correlation with prognosis, and provide a basis for the precise selection of CLDN18.2-targeted therapy.
Read the detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. One or two [68Ga]Ga-NODAGA-SNA014 PET scans will be performed according to disease stage and treatment plan. CLDN18.2 expression will be assessed by immunohistochemistry (IHC) in surgical specimens. The optimal SUV threshold and PET quantification potential for CLDN18.2 expression will be evaluated in comparison with histopathology, along with their correlation with prognosis.
- Keywords
- claudin 18.2, PET/CT, pancreatic cancer, gastric cancer, gastroesophageal junction cancer
- Medical subject headings
- Pancreatic Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| participants with pancreatic cancer, gastric cancer or GEJ cancer and CLDN18.2 expression | Participants with pancreatic cancer, gastric cancer or gastroesophageal junction (GEJ) cancer and immunohistochemistry (IHC)-confirmed CLDN18.2 expression at any level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value(SUV)
Participants include treatment-naive patients with upfront resectable disease, those becoming resectable after neoadjuvant or conversion therapy, and patients with recurrent disease that is either resectable or becomes resectable following treatment. One or two [68Ga]Ga-NODAGA-SNA014 positron emission tomography (PET) scans will be performed according to disease stage and treatment strategy, with claudin18.2 immunohistochemistry to be conducted on surgical specimens. Upfront resectable patients will undergo one preoperative scan, while patients requiring treatment prior to resection will receive one scan before treatment and an additional scan before surgery. The SUV values of tumor lesions will be measured on PET images.
Measured: Baseline and preoperative assessment at 3 weeks before surgery
The expression level of Claudin-18.2
Histopathologically confirmed pancreatic cancer or gastric/gastroesophageal junction cancer with any level of claudin 18.2 expression confirmed by immunohistochemistry (IHC) before enrollment. Claudin 18.2 expression will be further analyzed by IHC in surgical specimens.
Measured: Baseline and intraoperative specimen collection, assessment within 3 weeks postoperatively
Secondary outcomes (2)
Progress free survival
Progress free survival
Measured: 3 years
Overall survival
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Jiajia, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554742
- Sponsor's protocol ID
- RuijinH 2026-161
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Detection of Claudin18.2 in Pancreatic and Gastric/Gastroesophageal Junction Cancer by [68Ga]Ga-NODAGA-SNA014 PET Imaging
- ClinicalTrials.gov ID
- NCT07554742
- Acronym / sponsor ID
- RuijinH 2026-161
- Keywords
- claudin 18.2, PET/CT, pancreatic cancer, gastric cancer, gastroesophageal junction cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use Claudin 18.2 (CLDN18.2)-targeted positron emission tomography (PET) imaging technology to evaluate its detection efficacy and diagnostic threshold for CLDN18.2-positive pancreatic cancer and gastric/gastroesophageal junction cancer, analyze the quantitative value of PET parameters in CLDN18.2 expression and their correlation with prognosis, and provide a basis for the precise selection of CLDN18.2-targeted therapy.
Detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. One or two [68Ga]Ga-NODAGA-SNA014 PET scans will be performed according to disease stage and treatment plan. CLDN18.2 expression will be assessed by immunohistochemistry (IHC) in surgical specimens. The optimal SUV threshold and PET quantification potential for CLDN18.2 expression will be evaluated in comparison with histopathology, along with their correlation with prognosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants with pancreatic cancer, gastric cancer or GEJ cancer and CLDN18.2 expression | – | –Participants with pancreatic cancer, gastric cancer or gastroesophageal junction (GEJ) cancer and immunohistochemistry (IHC)-confirmed CLDN18.2 expression at any level. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible inpatients and outpatients from Ruijin Hospital
Key inclusion criteria (6 listed)
- Participants with histopathologically confirmed pancreatic cancer and gastric/gastroesophageal junction cancer with claudin 18.2 expression of any level, including treatment-naive patients with upfront resectable disease, patients with post-operative recurrent disease who are or become resectable following treatment, and patients rendered resectable after neoadjuvant or conversion therapy.
- Signed and dated informed consent form.
- Commitment to comply with research procedures and co-operation in the implementation of the full research process.
- Male or female participants.
- Aged 18-75 years old.
Key exclusion criteria (5 listed)
- Participants with prior Claudin 18.2 targeted therapy.
- Participants with concurrent other active malignancies.
- Participants with severe medical conditions that render them unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
- Pregnant women and women who may be pregnant, women who are breastfeeding.
- Participants with poor compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standardized uptake value(SUV)
Time frame: Baseline and preoperative assessment at 3 weeks before surgery
Participants include treatment-naive patients with upfront resectable disease, those becoming resectable after neoadjuvant or conversion therapy, and patients with recurrent disease that is either resectable or becomes resectable following treatment. One or two [68Ga]Ga-NODAGA-SNA014 positron emission tomography (PET) scans will be performed according to disease stage and treatment strategy, with claudin18.2 immunohistochemistry to be conducted on surgical specimens. Upfront resectable patients will undergo one preoperative scan, while patients requiring treatment prior to resection will receive one scan before treatment and an additional scan before surgery. The SUV values of tumor lesions will be measured on PET images.
The expression level of Claudin-18.2
Time frame: Baseline and intraoperative specimen collection, assessment within 3 weeks postoperatively
Histopathologically confirmed pancreatic cancer or gastric/gastroesophageal junction cancer with any level of claudin 18.2 expression confirmed by immunohistochemistry (IHC) before enrollment. Claudin 18.2 expression will be further analyzed by IHC in surgical specimens.
2 secondary outcomes
Progress free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Gastric Cancer, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LI Biao (13661777388, lb10363@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value(SUV) (time frame: Baseline and preoperative assessment at 3 weeks before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.