Breast Cancer Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 37 |
Est. completion date | December 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 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 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Uz Brussel | Brussels |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel | Kom Op Tegen Kanker |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Before injection up until 6 hrs after injection | |
Primary | 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. | Immediately after injection up to 3 hrs after injection | |
Primary | 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. | 10 min up to 3 hrs after injection | |
Primary | 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. | Resection of lesion up to 14 days after PET/CT |
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