Positron Emission TomographyNCT06203613
Clinical Study of CLDN18.2 PET/CT for Noninvasive Diagnosis of Gastric and Pancreatic Cancer
A study testing [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12 in people with Positron Emission Tomography and Pancreatic Neoplasms, run by YiHui Guan at 1 site in China.
Trial summary
In this study, we will investigate the diagnostic efficacy and safety of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers, and evaluate the sensitivity and specificity of the use of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for diagnosing metastatic gastric and pancreatic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Positron Emission Tomography, Pancreatic Neoplasms, Igestive System Neoplasms
- What is being tested?
- [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Age between 18 and 65 years old, gender is not limited. (2) Patients with gastric or pancreatic cancer confirmed by puncture or surgical pathology.
- Written informed consent signed by the subject or his/her legal guardian or caregiver.
- Willingness and ability to cooperate with all programs of this study.
Who cannot join
- (1) Severe hepatic or renal insufficiency; (2) Targeted therapy before radiotherapy or PET/CT scan. (3)Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
- History of serious surgery in the last month. (5) Those who have participated in other clinical trials during the same period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PET Center, Huashan Hospital, Fudan University
Shanghai, 200235
Yi Hui Guan, MD, 86-21-64285263 ext. 128, guanyihui@hotmail.com
About this study
In this study, we will investigate the diagnostic efficacy and safety of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers, and evaluate the sensitivity and specificity of the use of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for diagnosing metastatic gastric and pancreatic cancers . This study will provide a new method for the noninvasive target-specific diagnosis of gastric and pancreatic cancer, and provide intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.
- Being tested
- [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12Radiation
The dose of [18F]RCCB6 was calculated based on the patient's body weight to be 3.7 MBq [0.1 MCi]/kg, and the method of administration was intravenous push, with a single visualization administered once.
| Study group | Role | What they receive |
|---|---|---|
| patients with gastric cancer | Experimental | Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China. Receives: Radiation: [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12 |
| patients with pancreatic cancer | Experimental | Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China. Receives: Radiation: [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for the diagnosis of metastatic gastric and pancreatic cancer
In this study, we will first investigate the safety and feasibility of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers. The secondary goal of the clinical trial is to preliminary assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 or [68Ga]Ga-NOTA-3A12 PET/CT imaging for the diagnosis of metastatic gastric or pancreatic cancers.
Measured: 90mins from time of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positron Emission TomographyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YiHui Guan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YiHui Guan, Huashan Hospital
- Investigators
- Fang Xie, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203613
- Sponsor's protocol ID
- KY2023-1015
- Status last verified
- Feb 2024
- First submitted
- 3 Jan 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CLDN18.2 PET/CT for Noninvasive Diagnosis of Gastric and Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06203613
- Acronym / sponsor ID
- KY2023-1015
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- YiHui GuanUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 12 Jan 2024 (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.
In this study, we will investigate the diagnostic efficacy and safety of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers, and evaluate the sensitivity and specificity of the use of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for diagnosing metastatic gastric and pancreatic cancers . This study will provide a new method for the noninvasive target-specific diagnosis of gastric and pancreatic cancer, and provide intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with gastric cancer | Experimental | Radiation: [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China. |
| patients with pancreatic cancer | Experimental | Radiation: [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) Age between 18 and 65 years old, gender is not limited. (2) Patients with gastric or pancreatic cancer confirmed by puncture or surgical pathology.
Key exclusion criteria (2 listed)
- (1) Severe hepatic or renal insufficiency; (2) Targeted therapy before radiotherapy or PET/CT scan. (3)Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
- History of serious surgery in the last month. (5) Those who have participated in other clinical trials during the same period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12The dose of [18F]RCCB6 was calculated based on the patient's body weight to be 3.7 MBq [0.1 MCi]/kg, and the method of administration was intravenous push, with a single visualization administered once. | Radiation | patients with gastric cancer, patients with pancreatic cancer |
Primary outcome
To assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for the diagnosis of metastatic gastric and pancreatic cancer
Time frame: 90mins from time of injection
In this study, we will first investigate the safety and feasibility of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers. The secondary goal of the clinical trial is to preliminary assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 or [68Ga]Ga-NOTA-3A12 PET/CT imaging for the diagnosis of metastatic gastric or pancreatic cancers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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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. This study is not recruiting at the moment.
Fang Xie, PhD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]F-H3RESCA-3A12及[68Ga]Ga-NOTA-3A12 in people with Positron Emission Tomography and Pancreatic Neoplasms, run by YiHui Guan 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihui Guan, MD (13764308300 ext. +86, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for the diagnosis of metastatic gastric and pancreatic cancer (time frame: 90mins from time of injection). 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 16 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.