18F-HER2 PETNCT05983796
18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
A study testing 18F-HER2 PET in people with 18F-HER2 PET, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This is a open-label, one-arm, multicenter study aimed to explore the efficacy and safety of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- 18F-HER2 PET
- What is being tested?
- 18F-HER2 PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 30 Sep 2025
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent document must be signed.
- Aged 30-80 years old, both genders.
- Patients with locally advanced or advanced urothelial carcinoma
- Patients plan to undergo anti HER2 treatment.
Who cannot join
- Subjects with active malignancies other than urothelial carcinoma within 5 years should be excluded.
- Patients with severe liver, kidney, and hematopoietic diseases
- Patients with other mental disorders or primary emotional disorders
- Those who are unable to understand, comply with the research protocol, or sign an informed consent form
- PET imaging Contraindication (including pregnant women, lactating women, women of childbearing age who have a recent fertility plan, etc.)
- Individuals who are allergic to imaging agents
- Hypoglycemic reactions, severe pain, etc. cannot be accompanied by PET scans
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University School of medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Prospective Study of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
This is a open-label, one-arm, multicenter study aimed to explore the efficacy and safety of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
- Conditions
- 18F-HER2 PET
- Being tested
- 18F-HER2 PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-HER2 PETDiagnostic test
18F-HER2 PET
| Study group | Role | What they receive |
|---|---|---|
| 18F-HER2 PET | Experimental | Not described Receives: Diagnostic Test: 18F-HER2 PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start10 Aug 2023 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 18F-HER2 PETStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianzhen Shan, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983796
- Sponsor's protocol ID
- IIT20230066C
- Status last verified
- Jul 2023
- First submitted
- 2 Aug 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
- ClinicalTrials.gov ID
- NCT05983796
- Acronym / sponsor ID
- IIT20230066C
- Conditions
- 18F-HER2 PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 9 Aug 2023 (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 open-label, one-arm, multicenter study aimed to explore the efficacy and safety of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-HER2 PET | Experimental | Diagnostic Test: 18F-HER2 PET |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent document must be signed.
- Aged 30-80 years old, both genders.
- Patients with locally advanced or advanced urothelial carcinoma
- Patients plan to undergo anti HER2 treatment.
Key exclusion criteria (7 listed)
- Subjects with active malignancies other than urothelial carcinoma within 5 years should be excluded.
- Patients with severe liver, kidney, and hematopoietic diseases
- Patients with other mental disorders or primary emotional disorders
- Those who are unable to understand, comply with the research protocol, or sign an informed consent form
- PET imaging Contraindication (including pregnant women, lactating women, women of childbearing age who have a recent fertility plan, etc.)
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-HER2 PET18F-HER2 PET | Diagnostic test | 18F-HER2 PET |
Primary outcome
Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for 18F-HER2 PET
Not yet recruitingObservational study
Predicting Endocrine Resistance Using Molecular Imaging and Liquid Biopsy in Metastatic Breast Cancer
Metastatic Breast Cancer (HR+/ HER2-)
RecruitingObservational study
Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer
Breast Cancer, Breast Cancer, HER2-Expression
Active, not recruitingPhase 2
FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy
HER2/Neu Negative, Progesterone Receptor Negative
RecruitingPhase 3
ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients
Breast Carcinoma
RecruitingPhase 2
Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
Metastatic Breast Cancer ( HER2 Negative)
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.
Jianzhen Shan principal investigator
Zhejiang University
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-HER2 PET in people with 18F-HER2 PET, run by First Affiliated Hospital of Zhejiang University 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 7 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 9 Aug 2023. 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?
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?
Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma (time frame: up to 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 9 Aug 2023.