CNS Brain MetastasesNCT00585117
Pilot Study of (61)CuATSM-PET Imaging in Cancer Patients
A study testing PET-imaging with CuATSM, PET Imaging and PET CuATSM in people with CNS Brain Metastases and Head and Neck Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Hypoxia is a key factor in malignant progression of a neoplasm. It is our aim to explore the basis for quantitative in vivo tumor imaging by Cu-61 diacetyl-bis(N4-methylthiosemicarbazone)PET imaging as a surrogate of tissue hypoxia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Brain Metastases, Head and Neck Cancer, Lung Cancer
- What is being tested?
- PET-imaging with CuATSM, PET Imaging and PET CuATSM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jan 2012
- Phase
- Interventional
- 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
Who may be able to join
- Able to tolerated a PET/CT scan
- Age 18 or older
- Patient being considered for XRT for treatment of their cancer
- Able to provide written informed consent
Who cannot join
- severe claustrophobia or inability to tolerate the PET scan
- pregnant or breastfeeding women
- Patients that need supplemental oxygen
- Patients enrolled in experimental treatments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Hypoxia is a key factor in malignant progression of a neoplasm. It is our aim to explore the basis for quantitative in vivo tumor imaging by Cu-61 diacetyl-bis(N4-methylthiosemicarbazone)PET imaging as a surrogate of tissue hypoxia. We hypothesize that the hypoxia levels are predictive of the tumor response to therapy. Patients will have 2 CU-ATSM PET scans done and the goal is to show spatially stable tracer distributions that correlate with tumor hypoxia. This study will serve as a pilot study for a PO1 submission
- Conditions
- CNS Brain Metastases, Head and Neck Cancer, Lung Cancer, Prostate Cancer, Esophageal Cancer
- Being tested
- PET-imaging with CuATSM, PET Imaging, PET CuATSM, PET imaging with CuATSM
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-imaging with CuATSMProcedure or surgery
imaging with CuATSM
PET ImagingProcedure or surgery
Imaging with CuATSM
PET CuATSMProcedure or surgery
Imaging with CuATSM
PET imagingProcedure or surgery
imaging with CuATSM
PET imaging with CuATSMProcedure or surgery
Imaging with CuATSM
PET imaging with CuATSMProcedure or surgery
Imaging with CuATSM
| Study group | Role | What they receive |
|---|---|---|
| 1 CNS | Experimental | imaging with CuATSM Receives: Procedure: PET-imaging with CuATSM; Procedure: PET Imaging |
| 2. Head and Neck | Experimental | Imaging with CuATSM Receives: Procedure: PET CuATSM |
| 3. Lung | Experimental | imaging with CuATSM Receives: Procedure: PET imaging |
| 4. Prostate | Experimental | PET imaging with CuATSM Receives: Procedure: PET imaging with CuATSM |
| 5. Esophagus | Experimental | PET imaging with CuATSM Receives: Procedure: PET imaging with CuATSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia
Measured: end of study
Secondary outcomes (2)
To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans
Measured: end of study
To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startDec 2006
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: change in imaging priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Jeraj, Ph.D, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585117
- Sponsor's protocol ID
- HSC 2006-0282
- Other IDs
- RO06309, A533300, SMPH\HUMAN ONCOLOGY\HUMAN ONCO
- Status last verified
- Feb 2012
- First submitted
- 21 Dec 2007
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of (61)CuATSM-PET Imaging in Cancer Patients
- ClinicalTrials.gov ID
- NCT00585117
- Acronym / sponsor ID
- HSC 2006-0282
- Conditions
- CNS Brain Metastases, Head and Neck Cancer, Lung Cancer, Prostate Cancer, Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in imaging priorities
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Jan 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 is a key factor in malignant progression of a neoplasm. It is our aim to explore the basis for quantitative in vivo tumor imaging by Cu-61 diacetyl-bis(N4-methylthiosemicarbazone)PET imaging as a surrogate of tissue hypoxia. We hypothesize that the hypoxia levels are predictive of the tumor response to therapy. Patients will have 2 CU-ATSM PET scans done and the goal is to show spatially stable tracer distributions that correlate with tumor hypoxia. This study will serve as a pilot study for a PO1 submission
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 CNS | Experimental | Procedure: PET-imaging with CuATSM, Procedure: PET Imagingimaging with CuATSM |
| 2. Head and Neck | Experimental | Procedure: PET CuATSMImaging with CuATSM |
| 3. Lung | Experimental | Procedure: PET imagingimaging with CuATSM |
| 4. Prostate | Experimental | Procedure: PET imaging with CuATSMPET imaging with CuATSM |
| 5. Esophagus | Experimental | Procedure: PET imaging with CuATSMPET imaging with CuATSM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to tolerated a PET/CT scan
- Age 18 or older
- Patient being considered for XRT for treatment of their cancer
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- severe claustrophobia or inability to tolerate the PET scan
- pregnant or breastfeeding women
- Patients that need supplemental oxygen
- Patients enrolled in experimental treatments
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 |
|---|---|---|
| PET-imaging with CuATSMimaging with CuATSM | Procedure or surgery | 1 CNS |
| PET ImagingImaging with CuATSM | Procedure or surgery | 1 CNS |
| PET CuATSMImaging with CuATSM | Procedure or surgery | 2. Head and Neck |
| PET imagingimaging with CuATSM | Procedure or surgery | 3. Lung |
| PET imaging with CuATSMImaging with CuATSM | Procedure or surgery | 4. Prostate |
| PET imaging with CuATSMImaging with CuATSM | Procedure or surgery | 5. Esophagus |
Primary outcome
To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia
Time frame: end of study
2 secondary outcomes
To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans
Time frame: end of study
To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients
Time frame: end of study
Results and safety
The study was stopped early (reason given: change in imaging priorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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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.
Robert Jeraj, Ph.D principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-imaging with CuATSM, PET Imaging and PET CuATSM in people with CNS Brain Metastases and Head and Neck Cancer, run by University of Wisconsin, Madison at 1 site in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Dec 2019. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: change in imaging priorities). Results are not available in the source record.
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 validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia (time frame: end of study). 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 13 Dec 2019.