Brain CancerNCT01987193
Feasibility Study of Tumor Blood Flow Measurement by Detection of Positron Activation Post Proton Therapy (DS01)
An observational study of Brain Cancer and Prostate Cancer, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is the development of noninvasive (having no direct contact) detector and electronic system that will directly measure tumor blood flow rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, Prostate Cancer, Lung Cancer
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2018
- 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 treated at radiation oncology clinic
Who may be able to join
- Solid tumors in the intracranial, thoracic, or pelvic regions.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: Feasibility Study of Tumor Blood Flow Measurement by Detection of Positron Activation Post Proton Therapy
The purpose of this study is the development of noninvasive (having no direct contact) detector and electronic system that will directly measure tumor blood flow rate.
- Conditions
- Brain Cancer, Prostate Cancer, Lung Cancer
- Keywords
- Proton radiation, tumor blood flow
- Medical subject headings
- Brain Neoplasms, Prostatic Neoplasms, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with hypoxic tumor identified by tumor blood flow measurement.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Slow accrual; funding stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhong Su, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987193
- Sponsor's protocol ID
- UFPTI 1214 - DS01
- Status last verified
- May 2018
- First submitted
- 24 Oct 2013
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Tumor Blood Flow Measurement by Detection of Positron Activation Post Proton Therapy
- ClinicalTrials.gov ID
- NCT01987193
- Acronym / sponsor ID
- UFPTI 1214 - DS01
- Conditions
- Brain Cancer, Prostate Cancer, Lung Cancer
- Keywords
- Proton radiation, tumor blood flow
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual; funding stopped
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 19 Nov 2013 (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.
The purpose of this study is the development of noninvasive (having no direct contact) detector and electronic system that will directly measure tumor blood flow rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at radiation oncology clinic
Key inclusion criteria (1 listed)
- Solid tumors in the intracranial, thoracic, or pelvic regions.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients with hypoxic tumor identified by tumor blood flow measurement.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Slow accrual; funding stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Cancer
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical 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.
Zhong Su, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Cancer and Prostate Cancer, run by University of Florida 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 1 inclusion and 1 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 29 May 2018. 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: Slow accrual; funding stopped). 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?
Patients with hypoxic tumor identified by tumor blood flow measurement. (time frame: 3 months). 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 29 May 2018.