Molecular imaging of HER2 targeting tracer for tumor detection

Research for the Molecular Imaging of the HER2 Targeting Tracer

Not applicable Interventional Peking University Cancer Hospital & Institute · NCT04547309

This study is testing a new imaging method to see if it can help find and track HER2 positive tumors in patients, which could help tailor their cancer treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorPeking University Cancer Hospital & Institute Academic / other
Drugs / interventionstrastuzumab
Locations1 site (Beijing, Beijing Municipality)
Trial IDNCT04547309 on ClinicalTrials.gov

What this trial studies

This study aims to utilize a molecular PET radionuclide labeled HER2 Affibody to detect HER2 expression in primary and metastatic tumors in patients with HER2 positive or suspicious positive tumors. It focuses on assessing HER2 expression heterogeneity and monitoring changes in HER2 expression during treatment. By providing a non-invasive imaging method, the study seeks to identify patients suitable for anti-HER2 therapy and track treatment efficacy, thereby facilitating personalized cancer treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with HER2 positive or suspicious positive tumors and at least one measurable target lesion.

Not a fit: Patients with significant hepatic or renal dysfunction, or those who are pregnant, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the accuracy of HER2 status assessment, leading to better-targeted therapies for patients with HER2 positive tumors.

How similar studies have performed: Other studies have shown promise in using molecular imaging for HER2 detection, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

1. Significant hepatic or renal dysfunction;
2. Is pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refused to join the clinical research;
5. Suffering from claustrophobia or other mental disorders;
6. Any other situation that researchers considered it unsuitable to participate in the trial.

Where this trial is running

Beijing, Beijing Municipality

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions HER2 Positive or Suspicious Positive Tumors
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.