NCT04547309

Brief Summary

To use the molecular PET radionuclide (Ga-68 or F-18) labelled HER2 Affibody to detect the expression of HER2 in the primary and metastatic lesions in patients with HER2 positive or suspicious positive tumors; to detect the expression heterogeneity of HER2 in the lesions and inter-lesions; to observe the change of HER2 expression in the course of treatment. To provide an approach for screening patients high expression of HER2, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the individualized antitumor treatment of targeted drugs.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2020Aug 2026

First Submitted

Initial submission to the registry

September 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 21, 2025

Status Verified

August 1, 2024

Enrollment Period

6 years

First QC Date

September 7, 2020

Last Update Submit

March 18, 2025

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

    3 years

Study Arms (1)

68Ga/18F-HER2 Affibody PET/CT scan

EXPERIMENTAL
Radiation: 68Ga/18F-HER2 Affibody PET/CT scan

Interventions

68Ga/18F-HER2 Affibody PET/CT scanRADIATION

HER2 Affibody, labeled with PET radio-nuclide ( 68Ga or F-18) will be used as a molecular imaging tracer for PET/CT scan. All participants will undergo 68Ga/18F-HER2 Affibody PET/CT scan.

68Ga/18F-HER2 Affibody PET/CT scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged \> 18 years old; ECOG 0 or 1;
  • Patients with HER2 positive or suspicious positive tumors;
  • Has at least one measurable target lesion according to CT or MRI;
  • Life expectancy ≥ 12 weeks.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hua Zhu

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (4)

  • Guo X, Liu J, Ma H, Ma X, Liang X, Zhu H, Li C, Yang Z, Zhou N. Al 18 F-NOTA-HER2-BCH Versus 18 F-FDG PET/CT for Detecting Bone Metastases : Sensitivity and Quantitative Comparison. Clin Nucl Med. 2026 Feb 1;51(2):123-131. doi: 10.1097/RLU.0000000000006249. Epub 2025 Dec 22.

    PMID: 41474774DERIVED

  • Guo X, Liu J, Lin S, Gui X, Ding J, Liu T, Zhou N, Li S, Zhu H, Yang Z. Detectability of Al 18 F-NOTA-HER2-BCH PET for Nodal Metastases in Patients With HER2-Positive Breast Cancer. Clin Nucl Med. 2025 May 1;50(5):381-387. doi: 10.1097/RLU.0000000000005686. Epub 2025 Jan 24.

    PMID: 39854676DERIVED

  • Gui X, Liang X, Guo X, Yang Z, Song G. Impact of HER2-targeted PET/CT imaging in patients with breast cancer and therapeutic response monitoring. Oncologist. 2025 Jan 17;30(1):oyae188. doi: 10.1093/oncolo/oyae188.

    PMID: 39083323DERIVED

  • Guo X, Zhou N, Liu J, Ding J, Liu T, Song G, Zhu H, Yang Z. Comparison of an Affibody-based Molecular Probe and 18F-FDG for Detecting HER2-Positive Breast Cancer at PET/CT. Radiology. 2024 Jun;311(3):e232209. doi: 10.1148/radiol.232209.

    PMID: 38888484DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

September 7, 2020

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 21, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)