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MITIGATE-NeoBOM: A Study to Evaluate 68Ga- NeoBOMB1 in Patients With Advanced TKI-treated GIST Using PET/CT

NCT02931929 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-07-19

No results posted yet for this study

Summary

Tyrosine-kinase Inhibitors (TKI) resistance in gastrointestinal stromal tumours (GIST) is a common problem after prolonged treatment periods. The main objectives of this monocentric diagnostic Phase I/IIa study are safety and tolerability, pharmacokinetics and dosimetry of 68Ga-NeoBomb1 in GIST patients. The rationale behind this study is to improve diagnostic accuracy in GIST via positron-emission tomography/computer tomography (PET-CT) with a focus on TKI-resistant subtypes. Better detection, classification and definition of lesion extent are expected from the use of 68Ga-NeoBOMB1.

Conditions

Interventions

DRUG

68Ga-NeoBOMB1, 2-vial kit

intravenous application of a radiopharmaceutical for Positron Emission tomography (PET)

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Irene Virgolini, Univ-Prof.Dr · Head of department of nuclear medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-28
Primary Completion
2019-04-09
Completion
2019-04-09

Countries

  • Austria

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931929 on ClinicalTrials.gov