Clinical trial · Interventional
Research for the Molecular Imaging of the HER2 Targeting Tracer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Positive or Suspicious Positive Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga/18F-HER2 Affibody PET/CT scan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga/18F-HER2 Affibody PET/CT scan
- interventionNames
- Radiation: 68Ga/18F-HER2 Affibody PET/CT scan
Primary outcomes (1)
- measure
- SUV
- timeFrame
- 3 years
- description
- The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- DERIVEDGuo 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 41474774
- DERIVEDGuo 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 39854676
- DERIVEDGui 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 39083323
- DERIVEDGuo 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 38888484