Solid TumorsNCT07529002
Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors
An observational study of Solid Tumors, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This project is driven by clinical needs and focuses on the mucin (MUC) family, key glycopeptide antigens involved in mediating immune evasion in solid tumors. We selected multiple members of this family as research subjects. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Solid Tumors
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2026to 1 Mar 2028
- How long will I take part?
- 1 Year
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pathologically confirmed newly diagnosed solid tumors
Case inclusion criteria
- Patients with pathologically confirmed newly diagnosed solid tumors (such as melanoma, gastric cancer, colorectal cancer, etc.), or those with recent recurrence or suspected recurrence of previous solid tumors. Both male and female patients are eligible.
- Hematology, liver, and kidney function meeting the following criteria: Hematology: WBC ≥ 4.0×10⁹/L or neutrophil count ≥ 1.5×10⁹/L, PLT ≥ 100×10⁹/L, Hb ≥ 90 g/L; PT or APTT ≤ 1.5 × ULN. Liver and kidney function: T-Bil ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN for subjects with liver metastases), ALP ≤ 2.5 × ULN (if bone or liver metastases are present, ALP ≤ 4.5 × ULN); BUN ≤ 1.5 × ULN, SCr ≤ 1.5 × ULN.
- Expected survival ≥ 12 weeks.
- Good compliance with follow-up.
- Presence of at least one measurable target lesion according to RECIST 1.1 criteria.
- Female subjects must use effective contraception (effective contraception refers to sterilization, intrauterine hormone devices, condoms, contraceptive pills/agents, abstinence, or vasectomized partner) during the study and for 6 months after the study ends; male subjects must agree to use contraception during the study and for 6 months after the study ends.
- Subjects must fully understand and voluntarily participate in this trial, and sign the Informed Consent Form.
Case exclusion criteria
- Severe liver and kidney dysfunction.
- Women preparing for pregnancy, pregnant, or breastfeeding.
- Inability to lie flat for half an hour.
- Inability to provide informed consent.
- Suffering from claustrophobia or other psychiatric disorders.
- Known allergy to the investigational drug or its excipients.
- Other situations deemed unsuitable for trial participation by the researchers.
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 hosipitaal
Beijing, Beijing Municipality, 100142
Qian Zhang, 137655839835, 1806708691@qq.com
About this study
This project is driven by clinical needs and focuses on the mucin (MUC) family, key glycopeptide antigens involved in mediating immune evasion in solid tumors. We selected multiple members of this family as research subjects. Based on the MUC18 target, we developed the probe ⁸⁹Zr-SS-CNB001 (HuAA98-14, hereafter referred to as ⁸⁹Zr-s-C1). Studies have demonstrated that ⁸⁹Zr-s-C1 PET/CT enables noninvasive in vivo identification of tumor lesions in patients with solid tumors, and its imaging efficacy positively correlates with MUC18 expression levels in the patient's tumor tissue.
- Conditions
- Solid Tumors
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 |
|---|---|---|
| solid tumor | diagnosed solid tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the diagnostic and staging accuracy of ⁸⁹Zr-s-C1 PET/CT imaging in patients with MUC18-positive solid tumors, particularly for lesions that remain indeterminate with conventional imaging modalities or ¹⁸F-FDG PET/CT.
SUVmax and SUVmean
Measured: Imaging and analysis were performed 2, 24, and 48 hours after drug injection
Measure the maximum standardized uptake value (SUVmax) of tumor lesions and compare it with that of surrounding normal tissues (such as the liver and muscles) to calculate the tumor-to-background ratio (TBR).
SUVmax and SUVmean
Measured: Imaging and analysis were performed 2, 24, and 48 hours after drug injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start14 Apr 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Year
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
- NCT07529002
- Sponsor's protocol ID
- 2025KT202
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors
- ClinicalTrials.gov ID
- NCT07529002
- Acronym / sponsor ID
- 2025KT202
- Conditions
- Solid Tumors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 14 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 14 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.
This project is driven by clinical needs and focuses on the mucin (MUC) family, key glycopeptide antigens involved in mediating immune evasion in solid tumors. We selected multiple members of this family as research subjects. Based on the MUC18 target, we developed the probe ⁸⁹Zr-SS-CNB001 (HuAA98-14, hereafter referred to as ⁸⁹Zr-s-C1). Studies have demonstrated that ⁸⁹Zr-s-C1 PET/CT enables noninvasive in vivo identification of tumor lesions in patients with solid tumors, and its imaging efficacy positively correlates with MUC18 expression levels in the patient's tumor tissue.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| solid tumor | – | –diagnosed solid tumor |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pathologically confirmed newly diagnosed solid tumors
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
To evaluate the diagnostic and staging accuracy of ⁸⁹Zr-s-C1 PET/CT imaging in patients with MUC18-positive solid tumors, particularly for lesions that remain indeterminate with conventional imaging modalities or ¹⁸F-FDG PET/CT.
Time frame: Imaging and analysis were performed 2, 24, and 48 hours after drug injection
SUVmax and SUVmean
Measure the maximum standardized uptake value (SUVmax) of tumor lesions and compare it with that of surrounding normal tissues (such as the liver and muscles) to calculate the tumor-to-background ratio (TBR).
Time frame: Imaging and analysis were performed 2, 24, and 48 hours after drug injection
SUVmax and SUVmean
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 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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 Solid 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?
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 14 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 Zhangqian Zhang (13765839835, 1806708691@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the diagnostic and staging accuracy of ⁸⁹Zr-s-C1 PET/CT imaging in patients with MUC18-positive solid tumors, particularly for lesions that remain indeterminate with conventional imaging modalities or ¹⁸F-FDG PET/CT. (time frame: Imaging and analysis were performed 2, 24, and 48 hours after drug injection). 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 14 Apr 2026.