Imaging of Advanced Tumours Using [131]I-IAZA

NCT03427320 | Withdrawn Phase 1

• 1 other identifier: PK-IAZA-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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. 1.Demonstrate the safety of \[131\]I-IAZA
2. 2.To Determine the biodistribution and tumor avidity of \[131\]I-IAZA in patients with locally advanced or metastatic solid tumors.
3. 3.To determine the optimal imaging time of \[131\]I-IAZA SPECT.
4. 4.To collect data from imaging and plasma sampling for radiopharmacokinetic analysis of \[131\]I-IAZA.
5. 5.To determine whole body dosimetry of \[131\]I-IAZA in selected patients.
6. 6.To evaluate tumor dosimetry of \[131\]I-IAZA in patients with positive uptake.
7. 7.To determine the radiation dose accrued in hypoxic tumors.

Conditions

Locally Advanced Solid Tumors; Metastatic Solid Tumors

Keywords

[131]I-IAZA Imaging study

Outcome Measures

Primary Outcomes (4)

• Change in vital signs after [131]I-IAZA injection (first 10 patients)

  Vital signs are measured before injection of \[131\]I-IAZA and after the third and fourth scans

  Up to 36 hours post-injection

• Change in hematology/SMA-12 serum biochemistry after [131]I-IAZA injection (first 10 patients)

  Hematology and SMA-12 serum biochemistry will be performed before injection of \[131\]I-IAZA and after the fourth scan.

  Up to 36 hours post-injection

• Change in TSH level after [131]I-IAZA injection

  TSH blood test will be performed before injection of \[131\]I-IAZA and 5-7 weeks after \[131\]I-IAZA injection.

  Before [131]I-IAZA injection and 6 weeks ± 1 week after [131]I-IAZA injection

• Number of participants with adverse events.

  All participants will be evaluated for AE occurrence once \[131\]I-IAZA has been injected and for the following 8 days during which \[131\]I-IAZA scans will be acquired

  Up to 8 days after [131]I-IAZA injection

Secondary Outcomes (7)

• Biodistribution and tumor hypoxia avidity of [131]I-IAZA

  Up to 8 days

• Radioactivity of blood samples withdrawn at each imaging time point.

  Up to 8 days

• Estimating the whole body dosimetry of [131]IAZA in selected participants

  Up to 8 days

• Dose of [131]I-IAZA taken up by the tumor (in mSv/MBq) at each imaging time point in patients with positive uptake.

  Up to 8 days

• Dose (in mSv/MBq of [131]I-IAZA) to bone marrow

  Up to 8 days

Study Arms (1)

[131]I-IAZA whole body and SPECT imaging

EXPERIMENTAL

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.

Drug: [131]I-IAZA

Interventions

[131]I-IAZA DRUG

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.

Also known as: 131IAZA

[131]I-IAZA whole body and SPECT imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Study Officials

• Alexander JB McEwan, MB,FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: February 9, 2018
• Study Start: December 1, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 11, 2022

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)