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

NCT06548529 | Recruiting

• 1 other identifier: 2019KT114
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HER2 Positive or Suspicious Positive Tumors

Outcome Measures

Primary Outcomes (1)

• SUV

  The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT

  4 years

Study Arms (1)

Al18F-HER2-BCH PET/CT in bladder cancer patients

EXPERIMENTAL

Radiation: HER2 expression of PET imaging

Interventions

HER2 expression of PET imaging RADIATION

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

Al18F-HER2-BCH PET/CT in bladder cancer patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

uEXPLORER total-body PET/CT scanner (United Imaging, China)

Beijing, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 23, 2024

Record last verified: 2024-06

Locations

CN (1)