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NCT05535621
68Ga-HER2 Affibody PET/CT Imaging for HER2-Positive Cancer Patients
trial in HER2-Positive Cancer in 100 participants. Status unknown.
30 December 2024
Quick facts
| Lead sponsor | Tongji Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 18 December 2021 |
| Primary completion | 30 December 2024 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across China |
Conditions studied
- HER2-Positive Cancer — all drugs for HER2-Positive Cancer →
Sponsor
Tongji Hospital
Who can join
Adults 18 to 80, any sex, with HER2-Positive Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Detection of HER2 expression using <sup>99m</sup>Tc-NM-02 nanobody in patients with breast cancer: a non-randomized, non-blinded clinical trial.
Zhao L, Xing Y, Liu C, Ma S, et al · · 2024 · cited 10× · PMID 38459598 · DOI 10.1186/s13058-024-01803-y -
ImmunoPET Targeting Receptor Tyrosine Kinase: Clinical Applications.
Linguanti F, Abenavoli EM, Calabretta R, Berti V, et al · · 2023 · cited 2× · PMID 38136430 · DOI 10.3390/cancers15245886 -
Non-invasive assessment of HER2 expression in patients with urothelial carcinoma using [68Ga]Ga-HER2 affibody PET/CT imaging: preliminary clinical findings.
Zou S, Liu Z, Zhou J, Song S, et al · · 2025 · cited 1× · PMID 39951137 · DOI 10.1007/s00259-025-07142-0
Verify or expand the search:
- PubMed search for NCT05535621
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05535621 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tongji Hospital
- Last refreshed: 13 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05535621.
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