Trials / Completed
CompletedNCT04168528
Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT
Phase I/IIa Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of 68GaNOTA-Anti-MMR-VHH2, a New Radiopharmaceutical for in Vivo Imaging of Tumour-Associated Macrophages by Means of PET : UZBRU_VHH2_1
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Universitair Ziekenhuis Brussel · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase I study to evaluate the human safety and tolerability, biodistribution and dosimetry of 68GaNOTA-Anti-MMR-VHH2 Phase IIa study to evaluate tumour uptake of 68Ga-NOTA-anti-MMR-VHH2 in patients with breast cancer or melanoma. To correlate uptake of 68Ga-NOTA-anti-MMR-VHH2 in cancer lesions to immunohistological MMR staining after resection or biopsy of the same lesion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 68GaNOTA-Anti-MMR-VHH2 | Injection of the radiopharmaceutical and PET/CT imaging |
Timeline
- Start date
- 2019-11-05
- Primary completion
- 2024-12-04
- Completion
- 2024-12-04
- First posted
- 2019-11-19
- Last updated
- 2024-12-11
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04168528. Inclusion in this directory is not an endorsement.