Hypoxic TumoursNCT00756691
A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA
An observational study of Hypoxic Tumours, run by AHS Cancer Control Alberta.
Trial summary
Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's tumour that may help predict patient outcomes and/or help inform patient management decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because 18F-FAZA accumulates in hypoxic tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxic Tumours
- What is being tested?
- 18F-FAZA
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known primary or suspected metastatic carcinoma of the following: squamous cell carcinoma (SCC) of the head and neck, small (SCLC) and non-small cell lung cancer(NSCLC), Glioblastoma multiforme (GBM), lymphoma, or neuroendocrine tumours (NET).
Who may be able to join
- Male of Female > or = to 18 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test required
- Subjects with known primary or suspected metastatic SCC head and neck; NSCLC; SCLC; GBM; lymphoma, or NET with at least one lesion > 1 cm in diameter
- Able and willing to follow instructions and comply with the protocol
- Provide written informed consent prior to participation in the study
- Karnofsky Performance Scale Score of 70-100
Who cannot join
- Previous treatment for their primary or metastatic SCC head and neck, NSCLC, SCLC, GBM, Lymphoma, or NET
- Bilirubin > or = to 200 umol/L
- Creatinine > or - to 150 umol/L
- AST or ALT > or = to 5 times the upper limits of normal
- Serious medical conditions such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes
- Nursing or pregnant females
About this study
Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's tumour that may help predict patient outcomes and/or help inform patient management decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because 18F-FAZA accumulates in hypoxic tissues. This study is being done to learn more about the processes by which 18F-FAZA is absorbed, distributed, metabolized (built-up and broken down) and eliminated by the body.
Read the detailed description
A Phase I Radiopharmacokinetic and Radiodosimetric study of 18F-FAZA. Prior to treatment, subjects will receive a single injection of 18F-FAZA. Subjects will undergo a series of 5-5 PET scans, and will have 8-13 blood samples and 2 urine samples taken at specified time points over a 4.5-5.5 hour period. 18F-FAZA PET images will be reviewed to develop a dynamic uptake model, and blood and urine samples will be analyzed for unchanged 18F-FAZA and its metabolites.
- Conditions
- Hypoxic Tumours
- Being tested
- 18F-FAZA
- Keywords
- 18F-FAZA, Positron Emission Tomography, Radiation dosimetry, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAZAOther
Radioactive dose of 110-600 MBq per injection. A single pre-treatment injection of 18F-FAZA will be permitted per patient
| Study group | Role | What they receive |
|---|---|---|
| 1 | First 5 consecutive 18F-FAZA avid subjects that undergo up to 5 PET scans, 13 blood and 2 urine samples over 4.5 hours Receives: Other: 18F-FAZA | |
| 2 | Next 5 consecutive 18F-FAZA avid subjects that undergo up to 4 PET scans, 8 blood and 2 urine samples over 5.5 hours Receives: Other: 18F-FAZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses.
Measured: 2 years
Secondary outcomes (1)
To determine radiation dosimetry and optimal imaging times
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
Why it stopped: Limited scanner availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic TumoursStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander McEwan, MB, FRCPC, Principal investigator, Professor, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756691
- Sponsor's protocol ID
- PK-FAZ-003
- Status last verified
- Nov 2017
- First submitted
- 19 Sep 2008
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA
- ClinicalTrials.gov ID
- NCT00756691
- Acronym / sponsor ID
- PK-FAZ-003
- Conditions
- Hypoxic Tumours
- Keywords
- 18F-FAZA, Positron Emission Tomography, Radiation dosimetry, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Limited scanner availability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- First posted
- 22 Sep 2008 (estimated)
- 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.
Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's tumour that may help predict patient outcomes and/or help inform patient management decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because 18F-FAZA accumulates in hypoxic tissues. This study is being done to learn more about the processes by which 18F-FAZA is absorbed, distributed, metabolized (built-up and broken down) and eliminated by the body.
Detailed description
A Phase I Radiopharmacokinetic and Radiodosimetric study of 18F-FAZA. Prior to treatment, subjects will receive a single injection of 18F-FAZA. Subjects will undergo a series of 5-5 PET scans, and will have 8-13 blood samples and 2 urine samples taken at specified time points over a 4.5-5.5 hour period. 18F-FAZA PET images will be reviewed to develop a dynamic uptake model, and blood and urine samples will be analyzed for unchanged 18F-FAZA and its metabolites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: 18F-FAZAFirst 5 consecutive 18F-FAZA avid subjects that undergo up to 5 PET scans, 13 blood and 2 urine samples over 4.5 hours |
| 2 | – | Other: 18F-FAZANext 5 consecutive 18F-FAZA avid subjects that undergo up to 4 PET scans, 8 blood and 2 urine samples over 5.5 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known primary or suspected metastatic carcinoma of the following: squamous cell carcinoma (SCC) of the head and neck, small (SCLC) and non-small cell lung cancer(NSCLC), Glioblastoma multiforme (GBM), lymphoma, or neuroendocrine tumours (NET).
Key inclusion criteria (5 listed)
- Male of Female > or = to 18 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test required
- Subjects with known primary or suspected metastatic SCC head and neck; NSCLC; SCLC; GBM; lymphoma, or NET with at least one lesion > 1 cm in diameter
- Able and willing to follow instructions and comply with the protocol
- Provide written informed consent prior to participation in the study
- Karnofsky Performance Scale Score of 70-100
Key exclusion criteria (6 listed)
- Previous treatment for their primary or metastatic SCC head and neck, NSCLC, SCLC, GBM, Lymphoma, or NET
- Bilirubin > or = to 200 umol/L
- Creatinine > or - to 150 umol/L
- AST or ALT > or = to 5 times the upper limits of normal
- Serious medical conditions such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes
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 |
|---|---|---|
| 18F-FAZARadioactive dose of 110-600 MBq per injection. A single pre-treatment injection of 18F-FAZA will be permitted per patient | Other | 1, 2 |
Primary outcome
To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses.
Time frame: 2 years
1 secondary outcome
To determine radiation dosimetry and optimal imaging times
Time frame: 2 years
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 14 Nov 2017.
Related trials for Hypoxic Tumours
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
Not yet recruiting
Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response
Hepatocellular Carcinoma, Liver Cancer
Not yet recruitingEarly Phase 1
Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas
Glioma
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
RecruitingPhase 1/2
Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
Renal Cell Carcinoma
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 McEwan, MB, FRCPC principal investigator
Professor, Department of Oncology
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic Tumours, run by AHS Cancer Control Alberta.
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 5 inclusion and 6 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 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses. (time frame: 2 years). 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 14 Nov 2017.