Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I/IIa study to evaluate the uptake of 68NOTA-anti-MMR-VHH2, a new tracer for positron emission tomographic imaging (PET/CT scan) of breast cancer, head and neck cancer or melanoma

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitair Ziekenhuis Brussel
• Collaborator: Kom Op Tegen Kanker
• Treatments: Radiopharmaceuticals

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 with local, locally advanced or metastatic disease of breast cancer, head-and-neck cancer or melanoma, who is planned for resection or surgical biopsy of at least one lesion. In order to minimize partial volume effect the diameter of the tumor to be resected or biopsied 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