68Ga-HER2 Affibody PET/CT Imaging for HER2-Positive Cance... | NCT05535621

Studies
68Ga-HER2 Affibody PET/CT Imaging for HER2-Positive Cancer Patients

NCT05535621

Sponsor

Tongji Hospital

Status

Unknown status

Last Update Posted

Feb 13, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

HER2-Positive Cancer

Interventions

Not provided

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2021Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Sep 7, 2022

First Submission Date that Met QC Criteria

Sep 7, 2022

First Posted Date

Sep 10, 2022Actual

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

Feb 9, 2023

Last Update Posted Date

Feb 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The prevalence of HER2 alterations in pan-cancer indicates a broader range of application of HER2-targeted therapies. immunohistochemistry (IHC) or amplification by fluorescence in situ hybridization (FISH) is currently the most commonly used method for evaluation of HER-2 status in cancer patients. However, biopsies are spatiotemporally limited because of the highly heterogeneous expression of HER2. Patients with false-negative HER2 results may miss the chance for targeted therapy. Additionally, the HER2 status can change during the disease process.

A investigational imaging tracer named 68Ga-HER2 Affibody binds to HER-2 receptors. Previous studies in human have shown the efficacy of 68Ga-HER2 Affibody in detecting HER2 positive breast cancer and gastric cancer without any observed toxicity. However, studies are still insufficient and limited to breast cancer and gastric cancer.

The investigators hypothesized that 68Ga-HER2 Affibody PET imaging can noninvasively assess HER2 status in metastatic or recurrent solid tumors including breast cancer, gastrointestinal tumors, head and neck squamous tumors, bladder cancer, lung cancer and uterine tumors lesion. In this study, efficacy of 68Ga-HER2 Affibody in detecting HER2 positive cancer lesions and change of patient management based on 68Ga-HER2 Affibody PET will be determined.

Detailed Description

The prevalence of HER2 alterations in pan-cancer indicates a broader range of application of HER2-targeted therapies. Tumors including breast cancer, gastrointestinal tumors, head and neck squamous tumors, bladder cancer, lung cancer and uterine tumors exhibited high HER2 indices together with HER2 amplification or overexpression, which may benefit from HER2-targeted therapies.

immunohistochemistry (IHC) or amplification by fluorescence in situ hybridization (FISH) is currently the most commonly used method for evaluation of HER-2 status in cancer patients. However, biopsies are spatiotemporally limited because of the highly heterogeneous expression of HER2. Patients with false-negative HER2 results may miss the chance for targeted therapy. Additionally, the HER2 status can change during the disease process.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SUVmax	SUVmax	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with clinically diagnosed HER2-Positive tumor subjects need to sign the informed consent

Exclusion Criteria:

Pregnant women; renal failure (serum Cr>3mg/dl); Patients with claustrophobia

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

patients with HER2-Positive tumor

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ZHU XIAOHUA, DR	Contact	13971513770	18012908238	evazhu@vip.sina.com

Overall Officials

Name	Affiliation	Role
ZHU XIAOHUA, DR	Tongji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TongjiHospital	Recruiting	Wuhan	Hubei	430030	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39951137	Derived	Zou S, Liu Z, Zhou J, Song S, Wang D, Zhu D, Cheng S, Cheng Z, Zhu Y, Yu T, Pan D, Yang M, Zhu X. Non-invasive assessment of HER2 expression in patients with urothelial carcinoma using [68Ga]Ga-HER2 affibody PET/CT imaging: preliminary clinical findings. Eur J Nucl Med Mol Imaging. 2025 Jul;52(8):2782-2791. doi: 10.1007/s00259-025-07142-0. Epub 2025 Feb 14.