XCancer

Imaging of Advanced Tumours Using [131]I-IAZA

Description:

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 this is increased tumor growth, spread of the tumor and poor outcome. Early studies have shown that \[131\]I-IAZA scans can help detect if there are hypoxic cells in the tumor. A \[131\]I-IAZA scan is a nuclear medicine test used to create pictures of the whole body after \[131\]I-IAZA is injected into a vein. Further scientific research will help understand how \[131\]I-IAZA is distributed throughout the body and how it can be used to treat hypoxic tumor cells. The purpose of this study is to : 1. Demonstrate the safety of \[131\]I-IAZA 2. To Determine the biodistribution and tumor avidity of \[131\]I-IAZA in patients with locally advanced or metastatic solid tumors. 3. To determine the optimal imaging time of \[131\]I-IAZA SPECT. 4. To collect data from imaging and plasma sampling for radiopharmacokinetic analysis of \[131\]I-IAZA. 5. To determine whole body dosimetry of \[131\]I-IAZA in selected patients. 6. To evaluate tumor dosimetry of \[131\]I-IAZA in patients with positive uptake. 7. To determine the radiation dose accrued in hypoxic tumors.

Sponsor:

University of Alberta

Phase:

Phase 1/2

Contacts:

Alexander JB McEwan, MB,FRCPC (PRINCIPAL_INVESTIGATOR)

Government Study Link:

NCT03427320 - Click here to see study on

ClinicalTrials.gov

Inclusion
  • 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.
  • 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;
  • * Male or female ≥18 and ≤ 75 years of age;
Exclusion
  • Pregnant or breast feeding
  • Existing tracheostomy
  • Prior external beam radiation therapy to the only evaluable lesion
  • * Systemic therapy for tumors within 2 weeks;
  • Previously negative 18F-FAZA uptake of only evaluable lesion(s) within 3 months of enrolment.