Malignancies known to overexpress Gastrin-Releasing Peptide Receptors MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System
Conditions
Interventions
Product Name: [68Ga]-NeoBOMB1 50 µg, kit for radiopharmaceutical preparation
Product Code: Not applicable
Pharmaceutical Form: Kit for radiopharmaceutical preparation
Sponsors
Advanced Accelerator Applications International SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects must be at least 18 years of age •Subjects must have signed and dated an informed consent prior to any study-specific procedures. •Subjects with histologically-confirmed tumour, for whom a less than 6-month-old biopsy has been performed. •Dosimetry group: -Luminal breast cancer -Adenocarcinoma of the prostate •Non-dosimetry group: -Luminal breast cancer -Adenocarcinoma of the prostate -Small-cell lung cancer -Non-small cell lung cancer -Colorectal carcinoma •At least one malignant lesion detected via functional or morphological imaging (PET combined to appropriate tracer according to tumour type, CT, MRI) within 3 months prior to the administration of [68Ga]-NeoBOMB1. •The Eastern Cooperative Oncology (ECOG) performance status 0-2. •Subjects must agree to use highly effective methods of contraception (female partners of male participants should use highly effective methods of contraception) during the trial. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: •Renal insufficiency or an estimated Glomerular Filtration Rate (eGFR) 2 (Toxicity Grading Scale in vaccine clinical trials) •Participation in any other investigational trial within 30 days of study entry. •Subjects with positive pregnancy test (Urine dipstick), and/or currently breast-feeding •Concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results. •Concurrent bladder outflow obstruction or unmanageable urinary incontinence. •Known or expected hypersensitivity to 68Gallium, NeoBOMB1, or any excipient present in [68Ga]-NeoBOMB1. •Any condition that precludes raised arms position •Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide. •History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize preliminary targeting properties of [68Ga]-NeoBOMB1 in patients with malignancies known to overexpress GRPR.; Secondary Objective: •To assess safety and tolerability of a single diagnostic dose of [68Ga]-NeoBOMB1 administered as an intravenous bolus injection. •To assess the bio-distribution, pharmacokinetics, radiation dosimetry, and absorbed doses in critical organs for [68Ga]-NeoBOMB1 in a limited set of patients. •To establish the optimal threshold, expressed as Standardized Uptake Value (SUV), to discriminate Positron Emission Tomography (PET) imaging positive results from negative ones. •To estimate the [68Ga]-NeoBOMB1 PET imaging performance lesion-based and patient-based relative to a comparable standard imaging practice (eg PET, CT) according to the tumour type. •To estimate the [68Ga]-NeoBOMB1 PET diagnostic performance lesion-based and patient-based relative to the GRPR histopathology findings (e.g. IHC) ; Primary end point(s): •Number and location of tumour lesions detected by [68Ga]-NeoBOMB1 overall and for each tumour type •Calculation of the ratio tumour/background SUV and calculation of percentage absorbed dose in tumour overall and for each tumour type. ; Timepoint(s) of evaluation of this end point: Immediately after radiotracer injection, 4 scans with 6-7 bed positions will be acquired at approximately 15min, 1h±15min, 2h±15min and 4h±30min p.i. CT low dose attenuation scans will be acquired after every PET scan. PET data will be corrected for photon attenuation, dead-time, random events and scatter. A whole-body high dose CT will be acquired only if the conventional imaging of the patient is older than 1 month. Patients of the non-dosimetry group will undergo 2 whole-body PET/CT scans at 90±30 min and at 150±30 min. Patients with prostate cancer wil | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Standard safety parameters (clinical monitoring, laboratory, ECG) •Tolerability and safety of the administration of a diagnostic dose of [68Ga]-NeoBOMB1 in patients with malignancies known to overexpress GRPR as determined by absence of: -increased number of SAEs compared to other peptide-based radiotracers; -clinically relevant changes of physiological parameters (blood pressure, heart rate, ECG findings) •Generation of decay corrected tissue TACs from [68Ga]-NeoBOMB1 PET/CT images in normal organs, tumour lesions. •Quantification of urinary excretion of [68Ga]-NeoBOMB1 •Calculation of half-life of [68Ga]-NeoBOMB1 in blood •Generation of non-decay-corrected time activity curves from [68Ga]-NeoBOMB1 PET/CT images in normal organs, tumour lesions •Calculation of residence times in organs and tumour lesions of [68Ga]-NeoBOMB1 •Calculation of absorbed doses and effective whole body dose of [68Ga]-NeoBOMB1 •Calculation of the SUV of each lesion •Number and location of tumour lesion detected by [68Ga]-NeoBOMB1 in comparison with comparable standard imaging modalities such as FDG-PET •Calculation of the [68Ga]-NeoBOMB1 PET overall, positive and negative agreement on a lesion-by-lesion basis as well as on a patient basis relative to the standard imaging overall and for each tumour type •Comparison of number of patients with tumour lesions detected and number of tumour lesions detected by [68Ga]-NeoBOMB1 with cytology and/or histopathology from archival and/or recent biopsy specimens •Calculation of the [68Ga]-NeoBOMB1 PET sensitivity and specificity on a lesion-by-lesion basis for all lesions with associated biopsy data, and on a patient basis relative to histopathology / cytology data ; Timepoint(s) | — |
Countries
Austria
Contacts
Public ContactClinical trial team
Advanced Accelerator Applications International SA
Outcome results
None listed