Clinical trial · Interventional
Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients
Evaluation of 68GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients
NCT03331601CI-TRIAL-00113205terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Delay in recruitment
Summary
Brief summary (as posted)
This study investigates the uptake of the radiopharmaceutical 68-GaNOTA-Anti-HER2 VHH1 in brain metastasis using PET/CT imaging. Patients with HER2-positive and HER2-negative cancer will be included and the uptake in their lesions will be compared. Optional 68-GaNOTA-Anti-HER2 VHH1 scans may be performed during or after treatment, at time points 12±6 weeks and 24±9 weeks after the first scan.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Receptor, ErbB-2 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68GaNOTA-Anti-HER2 VHH1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The tumor targeting potential in brain metastasis
- timeFrame
- 90 min post injection
- description
- The tumor targeting potential in brain metastasis will be visually scored as positive or negative by an experienced nuclear medicine physician, unaware of the HER2-status.
- measure
- The tumor targeting potential in brain metastasis
- timeFrame
- 90 min post injection
- description
- The tumor targeting potential in brain metastasis will be assessed quantitatively using Standard Uptake Values (SUV) by an experienced nuclear medicine physician, unaware of the HER2-status.
Secondary outcomes (1)
- measure
- Change in uptake in brain lesions evaluated by PET/CT scan during or after treatment
- timeFrame
- up to 2 years after inclusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have given informed consent * Age 18 years or older * Patients with brain metastasized cancer, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI. * Patients with potentially HER2-positive cancer. Either a HER2 staining should have been done in standard of care, or sufficient tissue should be available for HER2-staining for study purpose. Exclusion Criteria: * Pregnant patients * Breast feeding patients * Patients with recent (\< 1 week) gastrointestinal disorders with diarrhea as major symptom * Patients with any serious active infection * Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical * Patients who cannot communicate reliably with the investigator * Patients at increased risk of death from a pre-existing concurrent illness
References
Publications (1)
- BACKGROUNDKeyaerts M, Xavier C, Heemskerk J, Devoogdt N, Everaert H, Ackaert C, Vanhoeij M, Duhoux FP, Gevaert T, Simon P, Schallier D, Fontaine C, Vaneycken I, Vanhove C, De Greve J, Lamote J, Caveliers V, Lahoutte T. Phase I Study of 68Ga-HER2-Nanobody for PET/CT Assessment of HER2 Expression in Breast Carcinoma. J Nucl Med. 2016 Jan;57(1):27-33. doi: 10.2967/jnumed.115.162024. Epub 2015 Oct 8. PMID 26449837