Solid TumorNCT05436093
CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors
A study testing 18F-FDG in people with Solid Tumor, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The objective of the study is to construct a noninvasive approach 68Ga-NC-BCH PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- 18F-FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2022to Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- 1. Aged >18 years old; ECOG 0 or 1;
- 2. Patients with solid tumors;
- 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
- 4. life expectancy >=12 weeks.
Who cannot join
- 1. Significant hepatic or renal dysfunction;
- 2. Is pregnant or ready to pregnant;
- 3. Cannot keep their states for half an hour;
- 4. Refusal to join the clinical study;
- 5. Suffering from claustrophobia or other mental diseases;
- 6. Any other situation that researchers think it is not suitable to participate in the experiment.
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, 1 recruiting
- Recruiting
Beijing cancer hospital
Beijing, Beijing Municipality, 100142
Hua Zhu, 010-88196495, zhuhuabch@pku.edu.cn
About this study
The objective of the study is to construct a noninvasive approach 68Ga-NC-BCH PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.
- Conditions
- Solid Tumor
- Being tested
- 18F-FDG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
All study participants will undergo one 18F-FDG PET/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NC-BCH | Experimental | Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-NC-BCH PET/CT scan. Receives: Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Uptake Value (SUV) of 68Ga-NC-BCH
SUV is a semiquantitative index commonly used in PET to quantify tissue metabolic activity, calculated as the ratio of the radioactivity concentration in the tissue of interest to the injected dose normalized by body weight. Bio-distribution of the tracer will be assessed by measuring the Standardized Uptake Value (SUV) in normal organs (e.g., liver, spleen, kidney) via PET/CT imaging at specified time points post-injection.
Measured: 2 years
Secondary outcomes (1)
Diagnostic performance
To evaluate the diagnostic permormance of 68Ga-NC-BCH PET/CT in identifying CLDN18.2-positive lesions, using immunohistochemistry (IHC)as the reference standard. The diagnostic performance will be assessed by receiver operating characteristic (ROC) curve analysis, with calculation of the area under the curve (AUC).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start23 Jun 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhu, Peking University Cancer Hospital & Institute
- Investigators
- Hua Zhu, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436093
- Sponsor's protocol ID
- 2022KT96
- Status last verified
- Mar 2026
- First submitted
- 23 Jun 2022
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors
- ClinicalTrials.gov ID
- NCT05436093
- Acronym / sponsor ID
- 2022KT96
- Conditions
- Solid Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jun 2022 (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 objective of the study is to construct a noninvasive approach 68Ga-NC-BCH PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NC-BCH | Experimental | Drug: 18F-FDGImaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-NC-BCH PET/CT scan. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Aged >18 years old; ECOG 0 or 1;
- 2. Patients with solid tumors;
- 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
- 4. life expectancy >=12 weeks.
Key exclusion criteria (6 listed)
- 1. Significant hepatic or renal dysfunction;
- 2. Is pregnant or ready to pregnant;
- 3. Cannot keep their states for half an hour;
- 4. Refusal to join the clinical study;
- 5. Suffering from claustrophobia or other mental diseases;
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-FDGAll study participants will undergo one 18F-FDG PET/CT scan. | Drug | 68Ga-NC-BCH |
Primary outcome
Standardized Uptake Value (SUV) of 68Ga-NC-BCH
Time frame: 2 years
SUV is a semiquantitative index commonly used in PET to quantify tissue metabolic activity, calculated as the ratio of the radioactivity concentration in the tissue of interest to the injected dose normalized by body weight. Bio-distribution of the tracer will be assessed by measuring the Standardized Uptake Value (SUV) in normal organs (e.g., liver, spleen, kidney) via PET/CT imaging at specified time points post-injection.
1 secondary outcome
Diagnostic performance
Time frame: 4 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 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
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Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
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Not yet recruitingPhase 2
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RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
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.
Hua Zhu principal investigator
Peking University Cancer Hospital & Institute
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-FDG in people with Solid Tumor, run by Peking University Cancer Hospital & Institute 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Aug 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 Hua Zhu (010-88196495, zhuhuabch@pku.edu.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) of 68Ga-NC-BCH (time frame: 2 years). 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 26 Aug 2026.