Adenocarcinoma of Head of PancreasNCT01455610
Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study
An observational study of Adenocarcinoma of Head of Pancreas, run by Meng Su Zeng at 6 sites in China.
Trial summary
The purpose of this multicenter and double-blind clinical trial is to prospectively assess the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its various post processing techniques, taking… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenocarcinoma of Head of Pancreas
- How many people
- 140 participants
- Where
- 6 sitesChina
- Study dates
- Oct 2011to Oct 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Out-patients or in-patients,with(or suspected) pancreatic head cancer, both have MDCT examinaton and receive surgery treatment
Who may be able to join
- Patients with (or suspected) pancreatic head cancer
- Being examined by contrasted-enhanced MDCT
- Receiving surgical treatment (including palliative surgery) in all research centers
Who cannot join
- Patients having (or suspected) pregnancy or breast-feeding
- Patients having allergic reactions to iodinated contrast agents or Hypersensitivity reactions to allergens(including drugs)
- Patients receiving ERCP before contrasted-enhanced MDCT examination
- Patients without surgery because of a high degree of surgical risk
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Radiology Department, Ruijing Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200025
Fuhua Yan, MD, PhD, +86-13764236797, Lin-xiaozhu-rj@hotmail.com
Fuhua Yan, MD, PhD
Radiology Department, Cancer Hospital, Fuandan University
Shanghai, Shanghai Municipality, 200032
Weijun Peng, Md, PhD, +86-13564682870, Huizhu171717@163.com
Weijun Peng, MD, PhD
Radiology Department, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Mengsu Zeng, MD, PhD, +86-021-64041990-2130, zengmengsu@gmail.com
Mengsu Zeng, MD, PhD
Radiology Department, Huadong Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Yanqing Hua, MD, PhD, +86-13774234090, 13774234090@163.com
Yanqing Hua, MD, PhD
Radiology Department, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Xiaoyuan Feng, MD, PhD, +86-13601659304, liangzh@vip.163.com
Xiaoyuan Feng, MD, PhD
Radiology Department, Changhai Hospital Affiliated to the Second Military Medical University
Shanghai, Shanghai Municipality, 200433
Jianping Lu, MD, PhD, +86-13701775219, 13701775219@163.com
Jianping Lu, MD, Phd
About this study
Official title: Preoperative Evaluation of Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study
The purpose of this multicenter and double-blind clinical trial is to prospectively assess the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its various post processing techniques, taking operational and pathological records as the gold standard.
- Conditions
- Adenocarcinoma of Head of Pancreas
- Keywords
- Computed tomography, Contrast enhancement, Pancreas, Cancer, Resectability
- Medical subject headings
- Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of Head of PancreasStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meng Su Zeng
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Shanghai Cancer Hospital, China, Ruijin Hospital, Huashan Hospital, Huadong Hospital
- Responsible party
- Sponsor-investigator, Meng Su Zeng, Shanghai Zhongshan Hospital
- Investigators
- Mengsu Zeng, MD, PhD, Study chair, Radiology Department, Zhongshan Hospital of Fudan UniversityJianping Lu, MD,PhD, Principal investigator, Radiology Department, Changhai Hospital Affiliated to Second Military Medical UniversityWeijun Peng, MD, PhD, Principal investigator, Radiology Department, Cancer Hospital Affiliated to Fudan UniversityFuhua Yan, MD, PhD, Principal investigator, Radiology Department, Ruijin Hospital Affiliated to Shanghai Jiaotong University, ChinaXiaoyuan Feng, MD, PhD, Principal investigator, Radiology Department, Huashan Hospital, Fudan University, ChinaYanqing Hua, MD, PhD, Principal investigator, Radiology Department, Huadong Hospital Affiliated to Fudan University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455610
- Sponsor's protocol ID
- ZMS-001
- Status last verified
- Oct 2011
- First submitted
- 18 Oct 2011
- Last updated
- 20 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Evaluation of Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study
- ClinicalTrials.gov ID
- NCT01455610
- Acronym / sponsor ID
- ZMS-001
- Conditions
- Adenocarcinoma of Head of Pancreas
- Keywords
- Computed tomography, Contrast enhancement, Pancreas, Cancer, Resectability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Meng Su ZengUniversity, hospital or other
- Collaborators
- Changhai Hospital, Shanghai Cancer Hospital, China, Ruijin Hospital, Huashan Hospital, Huadong Hospital
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 20 Oct 2011 (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 multicenter and double-blind clinical trial is to prospectively assess the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its various post processing techniques, taking operational and pathological records as the gold standard.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Out-patients or in-patients,with(or suspected) pancreatic head cancer, both have MDCT examinaton and receive surgery treatment
Key inclusion criteria (3 listed)
- Patients with (or suspected) pancreatic head cancer
- Being examined by contrasted-enhanced MDCT
- Receiving surgical treatment (including palliative surgery) in all research centers
Key exclusion criteria (4 listed)
- Patients having (or suspected) pregnancy or breast-feeding
- Patients having allergic reactions to iodinated contrast agents or Hypersensitivity reactions to allergens(including drugs)
- Patients receiving ERCP before contrasted-enhanced MDCT examination
- Patients without surgery because of a high degree of surgical risk
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2011.
Related trials for Adenocarcinoma of Head of Pancreas
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic 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.
Mengsu Zeng, MD, PhD study chair
Radiology Department, Zhongshan Hospital of Fudan University
Jianping Lu, MD,PhD principal investigator
Radiology Department, Changhai Hospital Affiliated to Second Military Medical University
Weijun Peng, MD, PhD principal investigator
Radiology Department, Cancer Hospital Affiliated to Fudan University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of Head of Pancreas, run by Meng Su Zeng at 6 sites in China.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
Contact Mengsu Zeng, MD, PhD (+86-021-64041990-2130, zengmengsu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 20 Oct 2011.