Gastrointestinal TumorsNCT04629326
PD-L1 Targeting Molecular Imaging of Solid Tumors
A study testing 68Ga-WL12 PET/CT in people with Gastrointestinal Tumors, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The objective of the study is to constrcut a noninvasive approach WL12 PET/CT to detect the PD-L1 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from anti-PD-1/L1 treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Tumors
- What is being tested?
- 68Ga-WL12 PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2021to Nov 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 years and older
- 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 Gastrointestinal 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.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Hua Zhu, +861088196495, zhuhuananjing@163.com
About this study
The objective of the study is to constrcut a noninvasive approach WL12 PET/CT to detect the PD-L1 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from anti-PD-1/L1 treatment.
- Conditions
- Gastrointestinal Tumors
- Being tested
- 68Ga-WL12 PET/CT
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-WL12 PET/CTOther
WL12, labeled with PET radio-nuclide ( Ga-68 )will be used as a molecular imaging tracer for PET/CT scanning
| Study group | Role | What they receive |
|---|---|---|
| Imaging cohort | Experimental | All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-WL12 PET/CT scans Receives: Other: 68Ga-WL12 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value（SUV）
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start20 Jul 2021
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal TumorsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629326
- Sponsor's protocol ID
- WL12-Tumor
- Status last verified
- Aug 2024
- First submitted
- 10 Nov 2020
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-L1 Targeting Molecular Imaging of Solid Tumors
- ClinicalTrials.gov ID
- NCT04629326
- Acronym / sponsor ID
- WL12-Tumor
- Conditions
- Gastrointestinal Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 16 Nov 2020 (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 constrcut a noninvasive approach WL12 PET/CT to detect the PD-L1 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from anti-PD-1/L1 treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging cohort | Experimental | Other: 68Ga-WL12 PET/CTAll study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-WL12 PET/CT scans |
Who may qualify
- Ages
- 18 years and older
- 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 Gastrointestinal 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 |
|---|---|---|
| 68Ga-WL12 PET/CTWL12, labeled with PET radio-nuclide ( Ga-68 )will be used as a molecular imaging tracer for PET/CT scanning | Other | Imaging cohort |
Primary outcome
Standardized uptake value（SUV）
Time frame: 2 years
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-WL12 PET/CT in people with Gastrointestinal Tumors, 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: status not confirmed, as of the sponsor's last update on 19 Aug 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 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） (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 19 Aug 2024.