Breast Cancer, Malignant Solid Tumor, Melanoma (Skin)
Conditions
Keywords
PET/CT, MMR-PET/CT, Macrophage PET/CT
Brief 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.
Interventions
Injection of the radiopharmaceutical and PET/CT imaging
Sponsors
Universitair Ziekenhuis Brussel
Kom Op Tegen Kanker
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PART I: Inclusion Criteria: Patients will only be included in the study if they meet all of the following criteria: * Patients who have given informed consent * Patients at least 18 years old * Patients with local, locally advanced or metastatic disease of a malignant solid tumor. In order to minimize partial volume effect the diameter of at least 1 tumor lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.
Exclusion criteria
Patients will not be included in the study if one of the following criteria applies: * Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher * Pregnant patients * Breast feeding patients * Patients with abnormal liver (Bilirubin ≥1.5 x ULN, ALT (SGPT) ≥3 x ULN) or kidney function (Serum creatinine clearance ≤50 ml/min as calculated with Cockcroft-Gault formula) * Patients with recent (\< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) 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 safety of the test radiopharmaceutical * Patients who cannot communicate reliably with the investigator * Patients who are unlikely to cooperate with the requirements of the study * Patients who are unwilling and/or unable to give informed consent * Patients at increased risk of death from a pre-existing concurrent illness * Patients who participated already in this study PART II: Inclusion Criteria: Patients will only be included in the study if they meet all of the following criteria: * Patients who have given informed consent * Patients at least 18 years old * Patients diagnosed with a local, locally advanced or metastatic disease, with any of the following cancer types : * Triple-negative breast carcinoma, * Hormone-receptor negative (HR-), HER2+ breast carcinoma, with HER2-expression defined as HER2+ on ISH or 3+ on IHC, as determined by local assessment on any of the available cancer tissues * Melanoma * Patients who have had a biopsy of at least one lesion or who are planned to undergo standard-of-care resection or biopsy of at least one lesion, in order to minimize partial volume effect, the diameter of that lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2: reported as type, frequency and severity (graded according to the CTCAEv5) (Part I). | Before injection up until 6 hrs after injection | Assessed using physical examination and blood sampling for hematology and clinical chemistry. |
| 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). | Immediately after injection up to 3 hrs after injection | Measured in standard uptake values in PET/CT imaging and expressed in relation to the injected activity. |
| 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). | 10 min up to 3 hrs after injection | Dosimetry will be calculated using the OLINDA software. |
| Tumor targeting potential using PET/CT and correlation to immunohistological MMR staining after resection: assessed using correlation coefficient (Part II). | Resection of lesion up to 14 days after PET/CT | PET/CT and immunohistochemistry will be assessed using a semi-quantitative scale. |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORTony LAHOUTTE, MD
Universitair Ziekenhuis Brussel
Outcome results
None listed