HER2 Expression of HER2 Affibody-based PET/CT to Predict... | NCT06548529

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

NCT06548529

Sponsor

Peking University Cancer Hospital & Institute

Status

Recruiting

Last Update Posted

Aug 23, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

HER2 Positive or Suspicious Positive Tumors

Interventions

HER2 expression of PET imaging

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Dec 1, 2028Estimated

First Submitted Date

Aug 7, 2024

First Submission Date that Met QC Criteria

Aug 7, 2024

First Posted Date

Aug 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2024

Last Update Posted Date

Aug 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Al18F-HER2-BCH PET/CT in bladder cancer patients	Experimental		Radiation: HER2 expression of PET imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SUV	The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT	4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
uEXPLORER total-body PET/CT scanner (United Imaging, China)	Recruiting	Beijing			China