Adenocarcinoma, PancreasNCT01703650
Role of Perfusion CT in Pancreatic Cancer
An observational study of Adenocarcinoma, Pancreas and Neuroendocrine Carcinoma of Pancreas, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is 1. to determine whether the perfusion parameters in the normal pancreas and the pancreas cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Pancreas, Neuroendocrine Carcinoma of Pancreas
- What is being tested?
- iopromide and CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Sep 2021
- 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: Resectable pancreas tumor group patients with resectable pancreas adenocarcinoma or neuroendocrine tumor Locally advanced pancreas tumor group Patients with locally advanced pancreas cancer
Who may be able to join
- patients who are older than eighteen years
- patients in whom operation and preoperative computed tomography are scheduled for resectable pancreas adenocarcinoma or pancreas neuroendocrine tumor
- patients in whom chemotherapy is scheduled for histologically confirmed pancreas adenocarcinoma
- patients in whom chemotherapy is planned for highly suspicious pancreas adenocarcinoma on imaging workup
- patients who agree with the study and whose informed consent is obtained.
Who cannot join
- patients who are younger than eighteen years old
- patients in whom previously radiation therapy was performed and the RTx field includes pancreas
- patients with recurred pancreas adenocarcinoma
- patient who are pregnant or nursing patients
- patients with renal failure (GFR<30mL/min)
- patients with history of malignancy, except malignancy is in complete remission after operation or iodine therapy for at least five years)
- patients with hypersensitivity for iodine or contrast media or other causes of contraindication of contrast-media enhanced CT scan
- Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Diagnostic Efficacy of Perfusion CT Using Wide Detector for Staging and Response Prediction After Chemotherapy in Pancreatic Cancer
The purpose of this study is
- to determine whether the perfusion parameters in the normal pancreas and the pancreas cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT
- to determine whether initial perfusion parameters as well as perfusion parameter change in pancreas adenocarcinoma before and after chemotherapy are different between chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD, PD according to RECIST 1.1).
Read the detailed description
- Performance of preoperative perfusion CT for preoperative staging is assessed by comparing with operative finding and histologic disease staging
- Estimation of initial or change of pancreas cancer perfusion parameters and whether those can provide cut-off value for predicting response of chemotherapy in patients with pancreas adenocarcinoma
- Being tested
- iopromide, CT
- Keywords
- CT, pancreas adenocarcinoma, RECIST, perfusion
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iopromideDrug
Also called Ultravist® (370mgI/mL)
- iopromide (370mgI/mL) enhanced perfusion CT will be performed within 14 days of operation.
- In patients who are planned to receive chemotherapy, iopromide enhanced perfusion CT was performed twice; within 14 days before starting 1st cycle and within 14 days after finishing 2nd cycle.
- iopromide (370mgI/mL) will be administered intravenously with an amount of 30mL (body weight[BW] <50kg) or 35 mL (50kg ≤BW <70kg) or 40 mL (70 kg≤BW <90kg) or 50 mL (90≤BW), followed by saline infusion (30mL).
- Injection rate is as follows; 6.0mL/sec if BW is <50kg, 7.0 mL/sec if BW is 50kg≤and <70kg, 8.0 mL/sec if BW is 70≤and<90kg and 9.0mL/sec if BW is 90kg≤.
CTProcedure or surgery
- Perfusion CT will be performed by using a 320 channel MDCT
- Patients are requested for fasting for at least 8 hours before CT scan.
- Patients are requested for doing shallow breathing as slow as possible and wide strap is applied during CT scan.
- Scan range is limited to the whole pancreas and it focuses to the pancreas tumor lesion.
- During perfusion CT, 19 phases (ten phases with two seconds interval and six phases with three seconds interval and three phases with five seconds interval) are obtained in fifty three seconds.
- ADIR 3D and SURE EXPOSURE 3D are applied during perfusion CT to minimize radiation dose.
| Study group | Role | What they receive |
|---|---|---|
| Resectable pancreas cancer | patients with resectable pancreas adenocarcinoma or neuroendocrine tumor underwent perfusion CT after intravenous iopromide administration Receives: Drug: iopromide; Procedure: CT | |
| Locally advanced Pancreas cancer | Patients with locally advanced pancreas cancer underwent perfusion CT after intravenous iopromide administration before and after chemotherapy. Receives: Drug: iopromide; Procedure: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the chemotherapy
Initial perfusion parameters (blood volume, blood flow and permeability) are compared between CTx-responder and non-responders after 6 cycle of the scheduled chemotherapy, using RECIST 1.1 criteria.
Measured: after 6 cycles of the planned chemotherapy
Secondary outcomes (3)
Correlation between change of perfusion parameters and the chemotherapy response
Perfusion parameters (blood volume, blood flow, and permeability) change between initial perfusion CT and second perfusion CT (which is taken after 2 cycle of the CTx) are compared between CTx-responder and non-responder after finishing 6 cycles of CTx according to RECIST 1.1 criteria.
Measured: after 6 cycles of the chemotherapy
Perfusion parameters among different pancreas tumors
Perfusion parameters (blood volume, blood flow and permeability) are compared among the different types of the pancreas tumors to investigate perfusion parameters can help characterization of the tumors.
Measured: within 2 months after finishing enrollment
comparison of perfusion parameters among the pancreas tumors and parenchyma
blood volume, blood flow and permeability are compared between the tumor and the pancreas parenchyma.
Measured: within three weeks before pancreas tumor surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2015
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma, PancreasStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703650
- Sponsor's protocol ID
- SNUH_ISS_2012
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2012
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Efficacy of Perfusion CT Using Wide Detector for Staging and Response Prediction After Chemotherapy in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01703650
- Acronym / sponsor ID
- SNUH_ISS_2012
- Keywords
- CT, pancreas adenocarcinoma, RECIST, perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2021 (estimated)
- First posted
- 10 Oct 2012 (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
- to determine whether the perfusion parameters in the normal pancreas and the pancreas cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT
- to determine whether initial perfusion parameters as well as perfusion parameter change in pancreas adenocarcinoma before and after chemotherapy are different between chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD, PD according to RECIST 1.1).
Detailed description
- Performance of preoperative perfusion CT for preoperative staging is assessed by comparing with operative finding and histologic disease staging
- Estimation of initial or change of pancreas cancer perfusion parameters and whether those can provide cut-off value for predicting response of chemotherapy in patients with pancreas adenocarcinoma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resectable pancreas cancer | – | Drug: iopromide, Procedure: CTpatients with resectable pancreas adenocarcinoma or neuroendocrine tumor underwent perfusion CT after intravenous iopromide administration |
| Locally advanced Pancreas cancer | – | Drug: iopromide, Procedure: CTPatients with locally advanced pancreas cancer underwent perfusion CT after intravenous iopromide administration before and after chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Resectable pancreas tumor group patients with resectable pancreas adenocarcinoma or neuroendocrine tumor Locally advanced pancreas tumor group Patients with locally advanced pancreas cancer
Key inclusion criteria (5 listed)
- patients who are older than eighteen years
- patients in whom operation and preoperative computed tomography are scheduled for resectable pancreas adenocarcinoma or pancreas neuroendocrine tumor
- patients in whom chemotherapy is scheduled for histologically confirmed pancreas adenocarcinoma
- patients in whom chemotherapy is planned for highly suspicious pancreas adenocarcinoma on imaging workup
- patients who agree with the study and whose informed consent is obtained.
Key exclusion criteria (8 listed)
- patients who are younger than eighteen years old
- patients in whom previously radiation therapy was performed and the RTx field includes pancreas
- patients with recurred pancreas adenocarcinoma
- patient who are pregnant or nursing patients
- patients with renal failure (GFR<30mL/min)
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 |
|---|---|---|
| iopromideAlso: Ultravist® (370mgI/mL)1. iopromide (370mgI/mL) enhanced perfusion CT will be performed within 14 days of operation. 2. In patients who are planned to receive chemotherapy, iopromide enhanced perfusion CT was performed twice; within 14 days before starting 1st cycle and within 14 days after finishing 2nd cycle. 3. iopromide (370mgI/mL) will be administered intravenously with an amount of 30mL (body weight[BW] <50kg) or 35 mL (50kg ≤BW <70kg) or 40 mL (70 kg≤BW <90kg) or 50 mL (90≤BW), followed by saline infusion (30mL). 4. Injection rate is as follows; 6.0mL/sec if BW is <50kg, 7.0 mL/sec if BW is 50kg≤and <70kg, 8.0 mL/sec if BW is 70≤and<90kg and 9.0mL/sec if BW is 90kg≤. | Drug | Locally advanced Pancreas cancer, Resectable pancreas cancer |
| CT1. Perfusion CT will be performed by using a 320 channel MDCT 2. Patients are requested for fasting for at least 8 hours before CT scan. 3. Patients are requested for doing shallow breathing as slow as possible and wide strap is applied during CT scan. 4. Scan range is limited to the whole pancreas and it focuses to the pancreas tumor lesion. 5. During perfusion CT, 19 phases (ten phases with two seconds interval and six phases with three seconds interval and three phases with five seconds interval) are obtained in fifty three seconds. 6. ADIR 3D and SURE EXPOSURE 3D are applied during perfusion CT to minimize radiation dose. | Procedure or surgery | Locally advanced Pancreas cancer, Resectable pancreas cancer |
Primary outcome
Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the chemotherapy
Time frame: after 6 cycles of the planned chemotherapy
Initial perfusion parameters (blood volume, blood flow and permeability) are compared between CTx-responder and non-responders after 6 cycle of the scheduled chemotherapy, using RECIST 1.1 criteria.
3 secondary outcomes
Correlation between change of perfusion parameters and the chemotherapy response
Time frame: after 6 cycles of the chemotherapy
Perfusion parameters among different pancreas tumors
Time frame: within 2 months after finishing enrollment
comparison of perfusion parameters among the pancreas tumors and parenchyma
Time frame: within three weeks before pancreas tumor surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- 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.
Jeong Min Lee, MD, PhD principal investigator
Seoul National University Hospital
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 Adenocarcinoma, Pancreas and Neuroendocrine Carcinoma of Pancreas, run by Seoul National University Hospital at 1 site in South Korea.
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 8 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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 South Korea. 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?
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?
Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the chemotherapy (time frame: after 6 cycles of the planned chemotherapy). 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 8 Oct 2020.