HER2 Expression of HER2 Affibody-based PET/CT to Predict Response in Bladder Cancer Patients Treated With ADC

August 21, 2024 updated by: Peking University Cancer Hospital & Institute

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • uEXPLORER total-body PET/CT scanner (United Imaging, China)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged # 18 years old; ECOG 0 or 1;
  2. Is unresectable or metastatic;
  3. Patients with HER2 positive or suspicious positive tumors;
  4. 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;
  5. Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;
  6. Receives anti-HER2 ADC treatment
  7. Life expectancy > 3 months

Exclusion Criteria:

  1. Significant hepatic or renal dysfunction;
  2. Is pregnant or ready to pregnant;
  3. Cannot keep their states for half an hour;
  4. Refused to join the clinical research;
  5. Suffering from claustrophobia or other mental disorders;
  6. Any other situation that researchers considered it unsuitable to participate in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Al18F-HER2-BCH PET/CT in bladder cancer patients
Radiation: HER2 expression of PET imaging
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019KT114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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