HER2 Positive or Suspicious Positive TumorsNCT06548529
HER2 Expression of HER2 Affibody-based PET/CT to Predict Response in Bladder Cancer Patients Treated With ADC
A study testing HER2 expression of PET imaging in people with HER2 Positive or Suspicious Positive Tumors, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value of HER2 expression in bladder cancer patients treated with HER2 ADC Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HER2 Positive or Suspicious Positive Tumors
- What is being tested?
- HER2 expression of PET imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged # 18 years old; ECOG 0 or 1;
- Is unresectable or metastatic;
- Patients with HER2 positive or suspicious positive tumors;
- was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane;
- Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;
- Receives anti-HER2 ADC treatment
- Life expectancy > 3 months
Who cannot join
- Significant hepatic or renal dysfunction;
- Is pregnant or ready to pregnant;
- Cannot keep their states for half an hour;
- Refused to join the clinical research;
- Suffering from claustrophobia or other mental disorders;
- Any other situation that researchers considered it unsuitable to participate in the trial.
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
uEXPLORER total-body PET/CT scanner (United Imaging, China)
Beijing
Xiaoyi Guo, PhD, 010-88196495, 15833916752@163.com
About this study
Official title: Al18F-HER2-BCH PET/CT to Predict Response in Bladder Cancer Patients Treated With HER2 ADC
To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value of HER2 expression in bladder cancer patients treated with HER2 ADC
- Being tested
- HER2 expression of PET imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER2 expression of PET imagingRadiation
Evaluate the diagnostic potential of HER2 imaging using 18F-labelled HER2 affibody , evaluate the predictive and prognostic value of HER2 PET imaging in bladder cancer patients treated with ADC
| Study group | Role | What they receive |
|---|---|---|
| Al18F-HER2-BCH PET/CT in bladder cancer patients | Experimental | Not described Receives: Radiation: HER2 expression of PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
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 posted12 Aug 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Positive or Suspicious Positive 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548529
- Sponsor's protocol ID
- 2019KT114
- Status last verified
- Jun 2024
- First submitted
- 7 Aug 2024
- Last updated
- 23 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Al18F-HER2-BCH PET/CT to Predict Response in Bladder Cancer Patients Treated With HER2 ADC
- ClinicalTrials.gov ID
- NCT06548529
- Acronym / sponsor ID
- 2019KT114
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 12 Aug 2024 (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.
To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value of HER2 expression in bladder cancer patients treated with HER2 ADC
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Al18F-HER2-BCH PET/CT in bladder cancer patients | Experimental | Radiation: HER2 expression of PET imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged # 18 years old; ECOG 0 or 1;
- Is unresectable or metastatic;
- Patients with HER2 positive or suspicious positive tumors;
- was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane;
- Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;
Key exclusion criteria (6 listed)
- Significant hepatic or renal dysfunction;
- Is pregnant or ready to pregnant;
- Cannot keep their states for half an hour;
- Refused to join the clinical research;
- Suffering from claustrophobia or other mental disorders;
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 |
|---|---|---|
| HER2 expression of PET imagingEvaluate the diagnostic potential of HER2 imaging using 18F-labelled HER2 affibody , evaluate the predictive and prognostic value of HER2 PET imaging in bladder cancer patients treated with ADC | Radiation | Al18F-HER2-BCH PET/CT in bladder cancer patients |
Primary outcome
SUV
Time frame: 4 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
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 23 Aug 2024.
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.
uEXPLORER total-body PET/CT scanner (United Imaging, China)
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HER2 expression of PET imaging in people with HER2 Positive or Suspicious Positive 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 7 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 23 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV (time frame: 4 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 23 Aug 2024.