Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT03427320
Status:
WITHDRAWN
Last Update Posted:
2022-07-11
First Post:
2017-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imaging of Advanced Tumours Using [131]I-IAZA
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
A Radiopharmacokinetic and Radiodosimetric Phase I/II Imaging Study of 1-alpha-D-(5-[131I]Iodo-5-deoxyarabinofuranosyl)-2-Nitroimidazole (131I-IAZA) in Patients With Locally Advanced or Metastatic Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Abandoned.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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.
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.
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 participants will be administered oral potassium iodide tablets to block radioactive iodine uptake in the thyroid. After administration of 185 MBq \[131\]I-IAZA (range: 150 - 220 MBq), all participants will undergo a series of up to six whole body planar scans on a dual headed gamma camera, and blood sampling for radiopharmacokinetic evaluation. A single fecal sample will be collected for up to 5 participants 24 - 72 hours post-injection, if possible, and assessed for total radioactivity. A safety evaluation will be conducted on the first 10 consecutively enrolled participants (safety sub-group), consisting of: Thyroid stimulating hormone (TSH) pre-injection and 6 weeks ±1 week post-injection; vital signs pre-injection and after scans 3 and 4; haematology, and SMA-12 serum biochemistry profile pre-injection and after scans 3 and 4; and an AE assessment at each imaging time point, up to 8 days post-injection. The safety evaluation for the remaining participants will consist of an AE assessment at each imaging time point, up to 8 days post-injection of \[131\]I-IAZA.
The radiodosimetry of \[131\]I-IAZA in different tissues will be determined in the first 5 consecutively enrolled participants from the planar images and the measured radioactivity in the fecal samples, if available. SPECT/CT imaging of the tumor(s) will be acquired at 19-36 hours post-injection for all the participants and will be used along with the planar images to determine the radiodosimetry and pattern of dose distribution within the tumor(s). Dosimetry data will be potentially correlated with the participants' health status, or other relevant information, as applicable .
The radiodosimetry of \[131\]I-IAZA in different tissues will be determined in the first 5 consecutively enrolled participants from the planar images and the measured radioactivity in the fecal samples, if available. SPECT/CT imaging of the tumor(s) will be acquired at 19-36 hours post-injection for all the participants and will be used along with the planar images to determine the radiodosimetry and pattern of dose distribution within the tumor(s). Dosimetry data will be potentially correlated with the participants' health status, or other relevant information, as applicable .
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: