Cohort 1: pathology-proven squamous cell carcinomas of the head and neck. Cohort 2: malignancy with a solid component Cohort 3: carotid plaque, planned for (SOC) carotid endarterectomy. Cohort 4: biopsy-proven Hodgkin (HL) or non-Hodgkin lymphoma (NHL). Cohort 5: Patients suspected for hemophagocytic lymphohistiocytosis (HLH), planned for (SOC) bone marrow biopsy.
Conditions
Interventions
Product Name: 68Ga-NOTA-Anti-MMR-VHH2
Pharmaceutical Form: Solution for injection
Sponsors
UZ Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort 1: Adult patients diagnosed with a squamous cell carcinoma of the head and neck (HNSCC) =10mm eligible for non-surgical therapy, independent of tumour stage. Cohort 2: Adult patients diagnosed with any malignancy (different from HNSCC) with a solid component =10mm, planned to receive immune checkpoint inhibition therapy. Cohort 3: Adult patients planned for surgical removal of an atherosclerotic plaque of the carotid artery by means of endarterectomy. Cohort 4: Adult patients diagnosed with Hodgkin or non-Hodgkin lymphoma with at least 1 lymphoma lesion of which the diameter should be = 10 mm in short axis for invaded adenopathies and = 10 mm in long axis for all other types of lesions. Cohort 5: Adult patients suspected for hemophagocytic lymphohisticytosis (HLH) (presence of = 3 clinical risk factors) and is planned for a standard-of-care bone marrow biopsy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher. - Pregnant patients - Breast feeding patients - 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 unwilling and/or unable to give informed consent - Patients at increased risk of death from a pre-existing concurrent illness - Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhoea as major symptom (cohort 1 and 2) - When a patient exhibits symptoms correlated with SARS-CoV-2, the patient should be tested using the standard of care testing protocol, prior to inclusion. When the test results indicate an active SARS-CoV-2-infection, the patient is excluded for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) To correlate uptake of 68GaNOTA-Anti-MMR-VHH2 of the selected lesion(s) with the therapeutic tumour response (cohorts 1 and 2) (2) To correlate uptake of 68GaNOTA-Anti-MMR-VHH2 with the expression of MMR using immunohistochemistry (cohort 3) (3) To evaluate uptake of 68GaNOTA-Anti-MMR-VHH2 in lymphoma-related lesions before start of treatment in Hodgkin and Non-Hodgkin lymphoma patients (cohort 4) (4) To correlate uptake of 68GaNOTA-Anti-MMR-VHH2 in central bone on PET/CT with the presence of hemophagocytosis in bone marrow samples, and the presence of clinical risk factors. ;Secondary Objective: Determine proportion of subject with HNSCC that show uptake on PET/CT(cohort 1). Assess the difference in uptake before and during or after treatment. Correlate this difference in uptake to time to treatment failure (cohort 1 and 2 (except radiotherapy). To characterise heterogeneity of uptake in patients with solid cancer lesions before and during or treatment (cohort 2). To correlate the uptake of 68GaNOTA-Anti-MMR-VHH2 in lymphoma-related lesions with the immunohistological MMR-staining on available lymphoma tissue before treatment (cohort 4) To correlate the uptake of 68GaNOTA-Anti-MMR-VHH2 in lymphoma-related lesions with serum MMR (sMMR) level at diagnosis (base-line) (cohort 4) To evaluate sMMR levels before, during and after treatment (cohort 4) To correlate serum MMR with the presence of hemophagocytosis in bone marrow samples (cohort 5) ;Primary end point(s): Cohort 1: - Uptake in cancer lesions on PET/CT 1 - Time to treatment failure - Status of patients for treatment failure at 6 months and 12 months after start of treatment (Y/N) Cohort 2: - Uptake in cancer lesions on PET/CT 1 - Time to treatment failure - Status of patients for treatment failure at 6 months and 12 months after start of treatment (Y/N) Cohort 3: - Uptake in excised atherosclerotic plaque on PET/CT 1 - Immunohistological MMR staining of excised atherosclerotic plaq | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cohort 1: - Uptake in contralateral normal tissue on PET/CT 1 - Uptake in cancer in lesions on PET/CT 2 Cohort 2: - Uptake in contralateral normal tissue on PET/CT 1 - Uptake in cancer in lesions on PET/CT 2 - Uptake in different areas of a cancer lesions of at least 20 mm on PET/CT 1 and PET/CT 2 Cohort 3: - Uptake in non-excised atherosclerotic plaques on PET/CT 1 Cohort 4: - Uptake in lymphoma-related lesions on MMR-PET/CT 1 - sMMR presence at baseline, at interim analysis, at end-of-treatment Cohort 5: - Uptake in bone marrow on MMR-PET/CT - sMMR presence ;Timepoint(s) of evaluation of this end point: Evaluations will be done in batch analysis. | — |
Countries
Belgium
Contacts
Public ContactMarleen Keyaerts
UZ Brussel
Outcome results
None listed