Liver CancerEarly Phase 1NCT03891654
Dynamic Contrast Enhanced Computed Tomography to Assess Radiation Therapy in Liver Cancer Patients
A Early Phase 1 study testing Dynamic Contrast Enhanced Computed Tomography in people with Liver Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a pilot study that uses a standard of care technique, Stereotactic Body Radiation Therapy (SBRT), in combination with Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to determine if perfusion changes from SBRT of liver cancer may be used for outcome assessment and prediction of prognosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Dynamic Contrast Enhanced Computed Tomography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 28 Apr 2022
- Phase
- Early Phase 1
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Be a Male or Female aged 18-100
- Diagnosed with Liver HCC or metastases
- Must be receiving or will plan to receive SBRT for Liver HCC or metastases
Who cannot join
- Allergy to iodine contrast
- CT with contrast not offered as a Standard of Care
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the Assessment of Radiation Therapy Outcome for Liver Cancer Patients
This is a pilot study that uses a standard of care technique, Stereotactic Body Radiation Therapy (SBRT), in combination with Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to determine if perfusion changes from SBRT of liver cancer may be used for outcome assessment and prediction of prognosis.
Read the detailed description
Patients will undergo standard of care SBRT while also receiving DCE-CT, also known as perfusion CT, pre-treatment, 6 hours post-treatment and 6 weeks post-treatment.
- Conditions
- Liver Cancer
- Being tested
- Dynamic Contrast Enhanced Computed Tomography
- Keywords
- Radiation, Metastases, Dynamic Contrast Enhanced Computed Tomography, Pilot
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Contrast Enhanced Computed TomographyDiagnostic test
Also called DCE-CT, Perfusion CT
Patients will receive DCE-CT prior to the start of standard of care, Stereotactic Body Radiation Therapy (SBRT), as well as 6 hours post administration of SBRT and 6 weeks post administration of SBRT.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Contrast Enhanced Computed Tomography | Experimental | DCE-CT, also known as perfusion CT, is a functional imaging modality that uses repeated computed tomography imaging after injection of an iodine based contrast agent. Receives: Diagnostic Test: Dynamic Contrast Enhanced Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCE-CT Perfusion Metrics: K-Trans
Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through K-Trans (extraction-flow product) as shown through DCE-CT imaging.
Measured: Baseline to end of follow-up, up to 12 weeks
DCE-CT Perfusion Metrics: Blood Volume
Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood volume as shown through DCE-CT imaging.
Measured: Baseline to end of follow-up, up to 12 weeks
DCE-CT Perfusion Metrics: Blood Flow
Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood flow as shown through DCE-CT imaging.
Measured: Baseline to end of follow-up, up to 12 weeks
Secondary outcomes (12)
Correlation Between Patient Demographics and K-Trans: Age
Stratify K-Trans results by age to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and K-Trans: Sex
Stratify K-Trans results by sex to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and K-Trans: Race
Stratify K-Trans results by race to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and K-Trans: Clinical Stage of Disease
Stratify K-Trans results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Age
Stratify blood volume results age to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Sex
Stratify blood volume results sex to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Race
Stratify blood volume results race to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Clinical Stage of Disease
Stratify blood volume results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Age
Stratify blood flow results age to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Sex
Stratify blood flow results sex to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Race
Stratify blood flow results race to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Clinical Stage of Disease
Stratify blood flow results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics
Measured: Post follow-up to end of study, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Aug 2019
- Primary completion20 Dec 2021
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patient will receive the standard of care, with the intervention, DCE-CT perfusion, occurring pre-treatment and post-treatment
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Moyed Miften, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891654
- Sponsor's protocol ID
- 18-2874.cc
- Other IDs
- P30CA046934
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2019
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the Assessment of Radiation Therapy Outcome for Liver Cancer Patients
- ClinicalTrials.gov ID
- NCT03891654
- Acronym / sponsor ID
- 18-2874.cc
- Conditions
- Liver Cancer
- Keywords
- Radiation, Metastases, Dynamic Contrast Enhanced Computed Tomography, Pilot
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 27 Mar 2019 (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.
This is a pilot study that uses a standard of care technique, Stereotactic Body Radiation Therapy (SBRT), in combination with Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to determine if perfusion changes from SBRT of liver cancer may be used for outcome assessment and prediction of prognosis.
Detailed description
Patients will undergo standard of care SBRT while also receiving DCE-CT, also known as perfusion CT, pre-treatment, 6 hours post-treatment and 6 weeks post-treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patient will receive the standard of care, with the intervention, DCE-CT perfusion, occurring pre-treatment and post-treatment
| Arm | Type | Receives |
|---|---|---|
| Dynamic Contrast Enhanced Computed Tomography | Experimental | Diagnostic Test: Dynamic Contrast Enhanced Computed TomographyDCE-CT, also known as perfusion CT, is a functional imaging modality that uses repeated computed tomography imaging after injection of an iodine based contrast agent. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Be a Male or Female aged 18-100
- Diagnosed with Liver HCC or metastases
- Must be receiving or will plan to receive SBRT for Liver HCC or metastases
Key exclusion criteria (3 listed)
- Allergy to iodine contrast
- CT with contrast not offered as a Standard of Care
- Pregnant women
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 |
|---|---|---|
| Dynamic Contrast Enhanced Computed TomographyAlso: DCE-CT, Perfusion CTPatients will receive DCE-CT prior to the start of standard of care, Stereotactic Body Radiation Therapy (SBRT), as well as 6 hours post administration of SBRT and 6 weeks post administration of SBRT. | Diagnostic test | Dynamic Contrast Enhanced Computed Tomography |
Primary outcome
DCE-CT Perfusion Metrics: K-Trans
Time frame: Baseline to end of follow-up, up to 12 weeks
Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through K-Trans (extraction-flow product) as shown through DCE-CT imaging.
DCE-CT Perfusion Metrics: Blood Volume
Time frame: Baseline to end of follow-up, up to 12 weeks
Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood volume as shown through DCE-CT imaging.
DCE-CT Perfusion Metrics: Blood Flow
Time frame: Baseline to end of follow-up, up to 12 weeks
Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood flow as shown through DCE-CT imaging.
12 secondary outcomes
Correlation Between Patient Demographics and K-Trans: Age
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and K-Trans: Sex
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and K-Trans: Race
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and K-Trans: Clinical Stage of Disease
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Age
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Sex
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Race
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Volume: Clinical Stage of Disease
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Age
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Sex
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Race
Time frame: Post follow-up to end of study, up to 12 months
Correlation Between Patient Demographics and Blood Flow: Clinical Stage of Disease
Time frame: Post follow-up to end of study, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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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.
Moyed Miften, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dynamic Contrast Enhanced Computed Tomography in people with Liver Cancer, run by University of Colorado, Denver 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 2 May 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DCE-CT Perfusion Metrics: K-Trans (time frame: Baseline to end of follow-up, up to 12 weeks). The study lists 3 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 2 May 2022.