Status:
WITHDRAWN
Imaging of Advanced Tumours Using [131]I-IAZA
Lead Sponsor:
University of Alberta
Conditions:
Locally Advanced Solid Tumors
Metastatic Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Hypoxic cells in tumors have less oxygen than normal cells do, which leads to several changes inside the cells that lead to genetic chages making these cells resistant to treatment. The end result of ...
Detailed Description
The proposed clinical trial will be a Phase I/II open-label, single site, radiopharmacokinetic and radiodosimetric study in participants with locally advanced or metastatic solid tumors. All participa...
Eligibility Criteria
Inclusion
- Male or female ≥18 and ≤ 75 years of age;
- Subjects with locally advanced or metastatic solid tumors with at least one lesion evaluable by CT or magnetic resonance imaging (MRI) of at least 1 cm (smallest diameter), as measured by Response Evaluation Criteria In Solid Tumors (RECIST) within 12 weeks of enrolment;
- Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase) ≤ 5 times the upper limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g/L within 2 weeks of enrolment;
- Haemoglobin concentration ≥ 90 g/L; white blood cell (WBC) count ≥ 3 x 109/L; platelets ≥ 75 x 109/L measured within 2 weeks of enrolment.
- Serum creatinine ≤ 150 µmol/L, and a calculated (Cockcroft-Gault) or estimated glomerular filtration rate (GFR) of ≥ 50 mL/min measured within 2 weeks of enrolment.
- Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment;
- Able and willing to follow instructions and comply with the protocol;
- Ability to provide written informed consent prior to participation in the study.
Exclusion
- Systemic therapy for tumors within 2 weeks;
- Prior external beam radiation therapy to the only evaluable lesion
- Existing tracheostomy
- Pregnant or breast feeding
- Previously negative 18F-FAZA uptake of only evaluable lesion(s) within 3 months of enrolment.
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
- Inability to complete the needed investigational examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation .
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03427320
Start Date
December 1 2018
End Date
April 1 2021
Last Update
July 11 2022
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2