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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
13
Injection of the radiopharmaceutical and PET/CT imaging
Uz Brussel
Brussels, Brussels Capital, Belgium
Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2: reported as type, frequency and severity (graded according to the CTCAEv5) (Part I).
Assessed using physical examination and blood sampling for hematology and clinical chemistry.
Time frame: Before injection up until 6 hrs after injection
Human biodistribution using blood sampling and PET/CT imaging: reported as relative uptake values per organ at 10, 90 and 150 minutes per individual subject and as a mean over all subjects (Part I).
Measured in standard uptake values in PET/CT imaging and expressed in relation to the injected activity.
Time frame: Immediately after injection up to 3 hrs after injection
Human dosimetry using PET/CT imaging data: radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I).
Dosimetry will be calculated using the OLINDA software.
Time frame: 10 min up to 3 hrs after injection
Tumor targeting potential using PET/CT and correlation to immunohistological MMR staining after resection: assessed using correlation coefficient (Part II).
PET/CT and immunohistochemistry will be assessed using a semi-quantitative scale.
Time frame: Resection of lesion up to 14 days after PET/CT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.