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Recruiting NCT06548529

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

No phase Interventional HER2 Positive or Suspicious Positive Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HER2 expression of PET imaging.
Who it may be relevant to
Registry conditions: HER2 Positive or Suspicious Positive Tumors. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Al18F-HER2-BCH PET/CT to Predict Response in Bladder Cancer Patients Treated With HER2 ADC

Overview

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

Interventions

  • 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

Primary outcome measures

  • SUV [Time frame: 4 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • uEXPLORER total-body PET/CT scanner (United Imaging, China) — Beijing

Identifiers

NCT: NCT06548529 · 2019KT114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗