Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT
NCT04168528 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2024-12-11
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
- Malignant Solid Tumor
- Breast Cancer
- Melanoma (Skin)
Interventions
- DRUG
-
68GaNOTA-Anti-MMR-VHH2
Injection of the radiopharmaceutical and PET/CT imaging
Sponsors & Collaborators
-
Kom Op Tegen Kanker
collaborator OTHER -
Universitair Ziekenhuis Brussel
lead OTHER
Principal Investigators
-
Tony LAHOUTTE, MD · Universitair Ziekenhuis Brussel
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-05
- Primary Completion
- 2024-12-04
- Completion
- 2024-12-04
Countries
- Belgium
Study Locations
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