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Imaging of Advanced Tumours Using [131]I-IAZA

NCT03427320 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-07-11

No results posted yet for this study

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 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.

Conditions

  • Locally Advanced Solid Tumors
  • Metastatic Solid Tumors

Interventions

DRUG

[131]I-IAZA

Injection of a single dose of 185MBq ( range 150-220MBq) of \[131\]I-IAZA prior to whole body imaging acquisition at 0-1 hrs,1-3 hrs , 4-8 hrs,19-36 hrs,41-72 hrs and 6-8 days post-injection. SPECT CT of target lesion(s) will be acquired at 19-36 hrs post injection.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Alexander JB McEwan, MB,FRCPC · University of Alberta

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Canada

Study Locations

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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 NCT03427320 on ClinicalTrials.gov