NCT05007548CompletedPhase 2
to Assess the Accuracy and Reliability of the Ga68-Dolacga Positron Emission Tomography Compared to Computer Tomography Volumetry and Indocyanine Green Retention Test for Measurement of Liver Reserve
An Open-label, Comparative Phase II Clinical Trial to Assess the Accuracy and Reliability of the Ga68-Dolacga Positron Emission Tomography Compared to Computer Tomography Volumetry and Indocyanine Green Retention Test for Measurement of Liver Reserve Among Scheduled Surgery Operation Patients
Source: ClinicalTrials.gov · Last updated 13 Dec 2023
Brief summary (registry, in English)
This is a phase 2 open-labeled study to compare the Ga68-Dolacga positron emission tomography with computer tomography volumetry and indocyanine green retention test for measurement of liver reserve among scheduled surgery operation patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 29 Jul 2021
- Start date
- 14 Dec 2021
- Primary completion date
- 20 Nov 2023
- Lead sponsor
- National Atomic Research Institute, Taiwan
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05007548
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 14 Dec 2021 to the primary completion date, 20 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A body weight loss of \>10% during the 6 months before operation;
Other illness
- Presence of seriously impaired function of vital organs due to respiratory, renal, or heart disease;
Other
- Presence of distant metastases;
- Cholangiocarcinoma;
- General PET exclusion criteria;
- Pregnant women, lactating or breast-feeding women;
- Patient who can't be followed up for any reason.
Who the study is looking for
- Scheduled operation subjects with diagnosed hepatic carcinoma. The eligibility criteria for operation refer to protocol Appendix II: Diagnosis and Treatment Guidelines for Hepatocellular Carcinoma in Chang Gung Memorial Hospital;
- Subjects without ascites or with controllable ascites;
- Serum total bilirubin level \< 2.0 mg/dL;
- Written informed consent must be obtained before any assessment is performed.
- Male or female subjects aged 20 or above, inclusive, at date of consent.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Linkon Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.