Neuroendocrine TumorsNCT01163526
Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
An observational study of Neuroendocrine Tumors and Brain (Nervous System) Cancers, run by Stanford University at 1 site in United States.
Trial summary
A research study of liver perfusion (how blood flows to the liver over time). We hope to learn whether perfusion characteristics of liver masses may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Brain (Nervous System) Cancers, Colon/Rectal Cancer
- What is being tested?
- CT perfusion
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jul 2016
- 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 must be 18 years or older. Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant.
Inclusion Criteria:3.1.1 Patients with suspected or biopsy-proven liver masses including unresectable hepatocellular carcinoma (HCC), unresectable colon cancer metastases to the liver, and metastatic neuroendocrine tumors to the liver will be eligible for enrollment.
3.1.2 Patients who have undergone prior chemotherapy more than one year prior to the study are eligible for enrollment.
3.1.4 Patients must be 18 years or older. Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant.
3.1.5 No life expectancy restrictions.
3.1.6 ECOG and Karnofsky Performance Status will not be employed.
3.1.7 Patients with renal failure are ineligible for this study (Glomerular filtration rate (GFR) must be > 60)
3.1.8 Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria:3.2.1 Patients who have undergone prior chemoembolization of hepatocellular carcinoma (HCC) are ineligible for enrollment. Patients who have undergone chemotherapy within one year prior to the study are also ineligible for enrollment.
3.2.2 No restrictions regarding use of other investigational agents.
3.2.3 Patients with severe contrast allergy are ineligible.
3.2.4 Patients who are pregnant or are trying to become pregnant are excluded from this study.
3.2.5 Patients who are cancer survivors or Human Immunodeficiency Virus (HIV)-positive will not be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
A research study of liver perfusion (how blood flows to the liver over time). We hope to learn whether perfusion characteristics of liver masses may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment.
- Conditions
- Neuroendocrine Tumors, Brain (Nervous System) Cancers, Colon/Rectal Cancer, Colon Cancer, Hepatobiliary Cancers, Hepatocellular Carcinoma (Hepatoma)
- Being tested
- CT perfusion
- Medical subject headings
- Neuroendocrine Tumors, Neurologic Manifestations, Neoplasms, Colonic Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT perfusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| neuroendocrine metastases | 15 patients with neuroendocrine metastases Receives: Procedure: CT perfusion | |
| colon cancer metastases | 15 patients with colon cancer metastases Receives: Procedure: CT perfusion | |
| HCC treated with cyberknife radiation and chemotherapy | 15 patients with HCC treated with cyberknife radiation and chemotherapy Receives: Procedure: CT perfusion | |
| HCC treated with Sirsphere embolization and chemotherapy | 15 patients with HCC treated with Sirsphere embolization and chemotherapy Receives: Procedure: CT perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predict RECIST response to treatment
Measured: at 3 months from CT perfusion parameters before and after treatment
Secondary outcomes (2)
Characterize CT perfusion longitudinally in both responders and nonresponders
Measured: 1 yr
Predict disease progression
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology, GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Aya Kamaya, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163526
- Sponsor's protocol ID
- HEP0031
- Other IDs
- SU-07092010-6491
- Status last verified
- Jan 2017
- First submitted
- 14 Jul 2010
- Last updated
- 30 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
- ClinicalTrials.gov ID
- NCT01163526
- Acronym / sponsor ID
- HEP0031
- Conditions
- Neuroendocrine Tumors, Brain (Nervous System) Cancers, Colon/Rectal Cancer, Colon Cancer, Hepatobiliary Cancers, Hepatocellular Carcinoma (Hepatoma)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology, GE Healthcare
- Study start
- Sep 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Jul 2010 (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.
A research study of liver perfusion (how blood flows to the liver over time). We hope to learn whether perfusion characteristics of liver masses may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| neuroendocrine metastases | – | Procedure: CT perfusion15 patients with neuroendocrine metastases |
| colon cancer metastases | – | Procedure: CT perfusion15 patients with colon cancer metastases |
| HCC treated with cyberknife radiation and chemotherapy | – | Procedure: CT perfusion15 patients with HCC treated with cyberknife radiation and chemotherapy |
| HCC treated with Sirsphere embolization and chemotherapy | – | Procedure: CT perfusion15 patients with HCC treated with Sirsphere embolization and chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must be 18 years or older. Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant.
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 |
|---|---|---|
| CT perfusion | Procedure or surgery | HCC treated with Sirsphere embolization and chemotherapy, HCC treated with cyberknife radiation and chemotherapy, colon cancer metastases, neuroendocrine metastases |
Primary outcome
Predict RECIST response to treatment
Time frame: at 3 months from CT perfusion parameters before and after treatment
2 secondary outcomes
Characterize CT perfusion longitudinally in both responders and nonresponders
Time frame: 1 yr
Predict disease progression
Time frame: 1 yr
Results and safety
The study was stopped early (reason given: accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
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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.
Aya Kamaya principal investigator
Stanford University
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 Neuroendocrine Tumors and Brain (Nervous System) Cancers, run by Stanford University 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?
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 30 Jan 2017. 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: accrual). 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?
Predict RECIST response to treatment (time frame: at 3 months from CT perfusion parameters before and after treatment). 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 30 Jan 2017.