MITIGATE-NeoBOM: A Study to Evaluate 68Ga- NeoBOMB1 in Patients With Advanced TKI-treated GIST Using PET/CT
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|ClinicalTrials.gov Identifier: NCT02931929|
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumors||Drug: 68Ga-NeoBOMB1, 2-vial kit||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MITIGATE-NeoBOMB1: A Phase I/IIa Study to Evaluate Safety, Biodistribution, Dosimetry+Preliminary Diagnostic Performance of 68Ga-NeoBOMB1 in Pat. With Advanced TKI-treated GIST Using Positron-emission Tomography/Computer Tomography (PET/CT)|
|Actual Study Start Date :||November 28, 2016|
|Actual Primary Completion Date :||April 9, 2019|
|Actual Study Completion Date :||April 9, 2019|
68Ga-NeoBOMB1, 2-vial kit for radiolabelling. I.v. Administration after radiolabelling
Drug: 68Ga-NeoBOMB1, 2-vial kit
intravenous application of a radiopharmaceutical for Positron Emission tomography (PET)
Other Name: NeoBOMB1
- Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: day 12-20 after administration ]Patients will undergo physical examinations, ECG, blood pressure measurements as well as analysis of blood biochemistry (haemoglobin, haematocrit, RBC count, WBC count, absolute neutrophil count, differential WBC count (neutrophils, eosinophils, basophils, lymphocytes, monocytes [%]), platelets), haematology (glucose, urea, creatinine, eGFR (calculated), bilirubin, Na, K, Cl, Ca, GOT [ASAT], GPT [ALAT], γGT, pancreas lipase and amylase, ALP, LDH, CK, CRP, serum albumin), coagulation parameters (Quick, INR, aPTT, fibrinogen) and semi-quantitative urine analysis (leukocytes, nitrite, erythrocytes, pH, protein). These measurements and assessments will be repeated during and after the application of 68Ga-NeoBOMB1. Prior to the study inclusion, prior to application of 68Ga-NeoBOMB1 and during the second follow-up a potential pregnancy will be assessed. The presence and severity of adverse events will be judged and reported according to CTCAE v4.03.
- Organ and compartment dosimetry data, human pharmacokinetics of 68Ga-NeoBOMB1 and identification of potentially dose-limiting organs [ Time Frame: 3-4 hours after administration ]
Pharmacokinetic data will be acquired by measuring 68Ga-NeoBOMB1 distribution over time through successive dynamic/semi-dynamic/static PET scans. Time activity curves will be generated to determine relative distribution among and doses for all relevant organs and compartments [% of injected radioactivity in MBq] through a physiology-based pharmacokinetic modelling approach (OLINDA/EXAM).
To gather more information, successive blood and urine sampling will also be used to provide blood activity and excretion information and estimate bloodpool/bone marrow doses.
- Preliminary targeting properties of 68Ga-NeoBOMB1 in advanced, GRP positive GIST tumours as assessed by SUV [ Time Frame: 3-4 hours after administration ]GIST lesion tracer accumulation will be assessed visually and measured as relative signal intensity (compared to blood pool activity, SUV) for known lesions.
- Targeting properties in comparison with standard imaging modalities such as FDG-PET or MRI as assessed by sensitivity and specificity [ Time Frame: 3-4 hours after administration ]The lesion demarcation from 68Ga-NeoBOMB1-PET will be compared to contrast-enhanced computed tomography and FDG-PET (if available).
- Qualitative comparison of targeting properties of 68Ga-NeoBOMB1 in resistant vs non-resistant tumour lesions in patients undergoing TKI Treatment as assessed by presence of tracer uptake and SUV [ Time Frame: 3-4 hours after administration ]Relative lesion growth tendency (as calculated from comparing current and previous CT scans) will be correlated to their respective tracer uptake (SUV).
- Identification of target tissue and improved target volume definition for potential locoregional treatment (RFA or external beam) [ Time Frame: 3-4 hours after administration ]
A comparison will be made whether 68Ga-NeoBOMB1-PET could offer additional information for a potential local therapy such as radiofrequency ablation (RFA) or external beam radiation as determined by definition of lesion amount and extent.
Therapeutic interventions will not be part of the current study
- To extrapolate absorbed tumour doses for potential application of 177Lu NeoBOMB1 (in first 6 patients) [ Time Frame: 3-4 hours after administration ]Estimation of tumour and organ/compartment doses will be performed by means of a physiology-based pharmacokinetic modelling to assess the potential feasibility of a therapeutic approach of 177Lu-NeoBOMB1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931929
|Medical University Innsbruck|
|Innsbruck, Tirol, Austria, 6020|
|Principal Investigator:||Irene Virgolini, Univ-Prof.Dr||Head of department of nuclear medicine|