Solid TumorsNCT07727317
Evaluate the Diagnostic Efficacy and Safety of INR 202 PET/CT Imaging in Participants With Advanced Solid Tumors
A study testing INR202+FDG in people with Solid Tumors, run by Shanghai Zhongshan Hospital.
Trial summary
This is a prospective, single-center, open-label clinical study comparing the imaging performance of INR202 PET/CT versus 18F-FDG PET/CT in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- INR202+FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jul 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- ECOG performance status of 0 or 1.
- Advanced solid tumors.
- Adequate organ functions.
- Life expectancy ≥6 months.
- Agreement to use contraceptive measures from the date of informed consent signing until 3 months after administration of INR202, and to avoid sperm or egg donation during this period.
- The participant (or legal guardian, where applicable) is fully informed of the purpose and procedures of the study, is able to understand the information provided, and voluntarily signs the informed consent form.
Who cannot join
- Unable to complete imaging examinations as required by the study protocol, in the investigator's judgement.
- With a history of ≥2 malignancies within 5 years prior to administration of INR202, except for adequately treated non-metastatic thyroid cancer, basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, or superficial bladder cancer.
- Known hypersensitivity to the active ingredient of INR202 or any of its components.
- Any medical condition or other situation that, in the investigator's judgement, may affect safety, compliance, or study outcomes.
About this study
Official title: A Clinical Study to Evaluate the Diagnostic Efficacy and Safety of INR 202 PET/CT Imaging in Participants With Advanced Solid Tumors
This is a prospective, single-center, open-label clinical study comparing the imaging performance of INR202 PET/CT versus 18F-FDG PET/CT in participants with advanced solid tumors.
- Conditions
- Solid Tumors
- Being tested
- INR202+FDG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INR202+FDGDiagnostic test
single administration
| Study group | Role | What they receive |
|---|---|---|
| INR202+FDG | Experimental | All eligible participants will receive a single administration of INR202 injection. A PET/CT scan will be performed post-dose. All subjects will undergo a follow-up visit during the safety follow-up period. Subsequently, subjects will undergo 18F-FDG PET/CT imaging. Receives: Diagnostic Test: INR202+FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of detected lesions
Measured: From Day 1 to Day 10
Secondary outcomes (1)
Adverse events
Measured: From Day 3 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727317
- Sponsor's protocol ID
- INR202-IIT-01
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 27 Jul 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Diagnostic Efficacy and Safety of INR 202 PET/CT Imaging in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07727317
- Acronym / sponsor ID
- INR202-IIT-01
- Conditions
- Solid Tumors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 27 Jul 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.
This is a prospective, single-center, open-label clinical study comparing the imaging performance of INR202 PET/CT versus 18F-FDG PET/CT in participants with advanced solid tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INR202+FDG | Experimental | Diagnostic Test: INR202+FDGAll eligible participants will receive a single administration of INR202 injection. A PET/CT scan will be performed post-dose. All subjects will undergo a follow-up visit during the safety follow-up period. Subsequently, subjects will undergo 18F-FDG PET/CT imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- ECOG performance status of 0 or 1.
- Advanced solid tumors.
- Adequate organ functions.
- Life expectancy ≥6 months.
Key exclusion criteria (4 listed)
- Unable to complete imaging examinations as required by the study protocol, in the investigator's judgement.
- With a history of ≥2 malignancies within 5 years prior to administration of INR202, except for adequately treated non-metastatic thyroid cancer, basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, or superficial bladder cancer.
- Known hypersensitivity to the active ingredient of INR202 or any of its components.
- Any medical condition or other situation that, in the investigator's judgement, may affect safety, compliance, or study outcomes.
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 |
|---|---|---|
| INR202+FDGsingle administration | Diagnostic test | INR202+FDG |
Primary outcome
Number of detected lesions
Time frame: From Day 1 to Day 10
1 secondary outcome
Adverse events
Time frame: From Day 3 to Day 7
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 27 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing INR202+FDG in people with Solid Tumors, run by Shanghai Zhongshan Hospital.
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 7 inclusion and 4 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of detected lesions (time frame: From Day 1 to Day 10). 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 27 Jul 2026.