CirrhosisGSANCT01350726
Functional-three-dimensional Reconstruction of Liver by 99MTc-GSA-SPECT Scan
An observational study of Cirrhosis and Hepatic Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The aims of this study were divided into three parts: 1. To develop a new software to carry out the functional-three- dimensional-reconstruction of the liver by 99mTc-GSA-SPECT scintigraphy 2. To probe a new dynamic model of the metabolism of the 99mTc-GSA. 3. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Hepatic Carcinoma
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Jul 2011
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects were from Peking Union Medical College Hospital from May, 2008 to the end of the study.
Who may be able to join
- Patients that with benign tumor、hepatitis and hepatic carcinoma (with or without cirrhosis)diagnosed by examination of CT, ultrasound-B, and/or pathology.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yilei Mao, M. D, Ph. D, +86-10-65296042, pumch.liver@hotmail.com
Yilei Mao, M. D, Ph. D
About this study
Official title: Functional-three-dimensional Reconstruction and Functional Evaluation of Liver by 99MTc-GSA-SPECT Scintigraphy
The aims of this study were divided into three parts:
- To develop a new software to carry out the functional-three- dimensional-reconstruction of the liver by 99mTc-GSA-SPECT scintigraphy
- To probe a new dynamic model of the metabolism of the 99mTc-GSA.
- To evaluate the liver function by 99mTc-GSA-SPECT scintigraphy before surgical treatment.
Study design:
- Collectivity type: Prospective，randomized, controlled, multi-central clinical study.
- Patients: The subjects were from different hospitals including: Peking Union Medical College Hospital (PUMCH).
Study arrangement:
This study was consisted of three parts:
- Conditions
- Cirrhosis, Hepatic Carcinoma
- Keywords
- Cirrhosis, Hepatic Carcinoma
- Medical subject headings
- Fibrosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal control | Subjects without liver cirrhosis and normal volunteers. | |
| Cirrhosis group | Subjects with liver cirrhosis. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJan 2008
- Primary completionMay 2011
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350726
- Sponsor's protocol ID
- PUMCH-Liver surgery -GSA
- Acronym
- GSA
- Status last verified
- May 2011
- First submitted
- 8 May 2011
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional-three-dimensional Reconstruction and Functional Evaluation of Liver by 99MTc-GSA-SPECT Scintigraphy
- ClinicalTrials.gov ID
- NCT01350726
- Acronym / sponsor ID
- GSA / PUMCH-Liver surgery -GSA
- Conditions
- Cirrhosis, Hepatic Carcinoma
- Keywords
- Cirrhosis, Hepatic Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 0 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 10 May 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 aims of this study were divided into three parts:
- To develop a new software to carry out the functional-three- dimensional-reconstruction of the liver by 99mTc-GSA-SPECT scintigraphy
- To probe a new dynamic model of the metabolism of the 99mTc-GSA.
- To evaluate the liver function by 99mTc-GSA-SPECT scintigraphy before surgical treatment.
Study design:
- Collectivity type: Prospective，randomized, controlled, multi-central clinical study.
- Patients: The subjects were from different hospitals including: Peking Union Medical College Hospital (PUMCH).
Study arrangement:
This study was consisted of three parts:
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal control | – | –Subjects without liver cirrhosis and normal volunteers. |
| Cirrhosis group | – | –Subjects with liver cirrhosis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects were from Peking Union Medical College Hospital from May, 2008 to the end of the study.
Key inclusion criteria (1 listed)
- Patients that with benign tumor、hepatitis and hepatic carcinoma (with or without cirrhosis)diagnosed by examination of CT, ultrasound-B, and/or pathology.
Key exclusion criteria (0 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
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 10 May 2011.
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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.
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 Cirrhosis and Hepatic Carcinoma, run by Peking Union Medical College Hospital at 1 site 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 1 inclusion and 0 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 10 May 2011. 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 10 May 2011.