Locally Advanced Solid TumorsPhase 1/2NCT03427320
Imaging of Advanced Tumours Using [131]I-IAZA
A Phase 1/2 study testing [131]I-IAZA in people with Locally Advanced Solid Tumors and Metastatic Solid Tumors, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- [131]I-IAZA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2018to Apr 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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
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 :
- Demonstrate the safety of [131]I-IAZA
- To Determine the biodistribution and tumor avidity of [131]I-IAZA in patients with locally advanced or metastatic solid tumors.
- To determine the optimal imaging time of [131]I-IAZA SPECT.
- To collect data from imaging and plasma sampling for radiopharmacokinetic analysis of [131]I-IAZA.
- To determine whole body dosimetry of [131]I-IAZA in selected patients.
- To evaluate tumor dosimetry of [131]I-IAZA in patients with positive uptake.
- To determine the radiation dose accrued in hypoxic tumors.
Read the 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 .
- Being tested
- [131]I-IAZA
- Keywords
- [131]I-IAZA Imaging study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[131]I-IAZADrug
Also called 131IAZA
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.
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: Drug: [131]I-IAZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 8 days after [131]I-IAZA injection
Secondary outcomes (7)
Biodistribution and tumor hypoxia avidity of [131]I-IAZA
Analysis of [131]I-IAZA whole body scans and SPECT-CT for biodistribution of [131]I-IAZA
Measured: Up to 8 days
Radioactivity of blood samples withdrawn at each imaging time point.
Radioactivity will be measured in blood samples collected at each imaging time point.
Measured: Up to 8 days
Estimating the whole body dosimetry of [131]IAZA in selected participants
The radiodosimetry of [131]I-IAZA will be determined by outlining organs of significant uptake on the planar images and determining the dose to each normal organ.
Measured: 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.
The tumor activity values will be determined from [131]I-IAZA scans and combined into time-activity curves.
Measured: Up to 8 days
Dose (in mSv/MBq of [131]I-IAZA) to bone marrow
The bone marrow absorbed dose will be calculated using the blood activity and dosimetry data from the [131]I-IAZA whole body scans.
Measured: Up to 8 days
Time to maximum [131]I-IAZA uptake
The activity values of different organs will be determined form [131]I-IAZA scans and combined into time-activity curves.
Measured: Up to 8 days
Clearance characteristics of [131]IAZA
[131]I-IAZA scans will be analyzed for the rate and organs involved in clearance of [131]I-IAZA from the body.
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study startDec 2018 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: Abandoned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander JB McEwan, MB,FRCPC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427320
- Sponsor's protocol ID
- PK-IAZA-001
- Status last verified
- Feb 2018
- First submitted
- 20 Dec 2017
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03427320
- Acronym / sponsor ID
- PK-IAZA-001
- Keywords
- [131]I-IAZA Imaging study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Abandoned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Demonstrate the safety of [131]I-IAZA
- To Determine the biodistribution and tumor avidity of [131]I-IAZA in patients with locally advanced or metastatic solid tumors.
- To determine the optimal imaging time of [131]I-IAZA SPECT.
- To collect data from imaging and plasma sampling for radiopharmacokinetic analysis of [131]I-IAZA.
- To determine whole body dosimetry of [131]I-IAZA in selected patients.
- To evaluate tumor dosimetry of [131]I-IAZA in patients with positive uptake.
- 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 .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [131]I-IAZA whole body and SPECT imaging | Experimental | Drug: [131]I-IAZAInjection 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [131]I-IAZAAlso: 131IAZAInjection 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 whole body and SPECT imaging |
Primary outcome
Change in vital signs after [131]I-IAZA injection (first 10 patients)
Time frame: Up to 36 hours post-injection
Vital signs are measured before injection of [131]I-IAZA and after the third and fourth scans
Change in hematology/SMA-12 serum biochemistry after [131]I-IAZA injection (first 10 patients)
Time frame: Up to 36 hours post-injection
Hematology and SMA-12 serum biochemistry will be performed before injection of [131]I-IAZA and after the fourth scan.
Change in TSH level after [131]I-IAZA injection
Time frame: Before [131]I-IAZA injection and 6 weeks ± 1 week 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.
Number of participants with adverse events.
Time frame: Up to 8 days after [131]I-IAZA injection
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
7 secondary outcomes
Biodistribution and tumor hypoxia avidity of [131]I-IAZA
Time frame: Up to 8 days
Radioactivity of blood samples withdrawn at each imaging time point.
Time frame: Up to 8 days
Estimating the whole body dosimetry of [131]IAZA in selected participants
Time frame: 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.
Time frame: Up to 8 days
Dose (in mSv/MBq of [131]I-IAZA) to bone marrow
Time frame: Up to 8 days
Time to maximum [131]I-IAZA uptake
Time frame: Up to 8 days
Clearance characteristics of [131]IAZA
Time frame: Up to 8 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced Solid Tumors, Recurrent Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander JB McEwan, MB,FRCPC principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [131]I-IAZA in people with Locally Advanced Solid Tumors and Metastatic Solid Tumors, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vital signs after [131]I-IAZA injection (first 10 patients) (time frame: Up to 36 hours post-injection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.