Hepatocellular CarcinomaNCT06148155
A Study of [68Ga]Ga-NOTA-RG2 PET Imaging in the Diagnosis of Hepatocellular Carcinoma
A study testing [68Ga]Ga-NOTA-RG2 PET Imaging in people with Hepatocellular Carcinoma, run by Huashan Hospital at 1 site in China.
Trial summary
The aim of this study was to establish and optimize the imaging method of [68Ga]Ga-NOTA-RG2, as well as its physiological and pathological distribution characteristics, and on this basis to evaluate the diagnostic efficacy of the above imaging agents in patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- [68Ga]Ga-NOTA-RG2 PET Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jun 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatocellular carcinoma patients
- Age between 18 and 65 years old, gender is not limited.
- Patients with suspicious intrahepatic spaces detected by MR and considered to be hepatocellular carcinoma with AFP>200 ug/L who have not undergone surgery.
- Patients with hepatocellular carcinoma confirmed by puncture pathology
- Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
- Willingness and ability to cooperate with all programs of the study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Patients receiving anti-tumor therapy prior to the PET/CT scan.
- Suffering from severe other neurological disorders, or gastrointestinal, cardiovascular, hepatic, renal, hematologic, respiratory, immunodeficiency, and other serious diseases.
- Alternative subjects with conditions that contraindicate PET/CT scanning. This includes, but is not limited to, elevated blood glucose that is not effectively controlled; pregnant, lactating, or breastfeeding women; those who are unable to receive repeated intravenous injections; those who may be hypersensitive to the drug and its components (including a history of severe allergies or anaphylactic reactions, especially to the drug being examined); and hermetic phobias.
- Within the past year, have participated in other research protocols or clinical care, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv.
- Alternative subjects have undergone major surgery within the last 3 months; experimental drug or device therapy (of uncertain efficacy or safety) within 1 month
- The alternate subject has any clinical condition that, in the opinion of the Sponsor of this study, may cause or has the potential to cause harm from this agent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, 200040
Yihui Guan, +8613764308300, guanyihui@hotmail.com
About this study
Official title: A Study of [68Ga]Ga-NOTA-RG2 PET Imaging in the Diagnosis of Hepatocellular
The aim of this study was to establish and optimize the imaging method of [68Ga]Ga-NOTA-RG2, as well as its physiological and pathological distribution characteristics, and on this basis to evaluate the diagnostic efficacy of the above imaging agents in patients with hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- [68Ga]Ga-NOTA-RG2 PET Imaging
- Keywords
- Hepatocellular Carcinoma, Positron-Emission Tomography
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-NOTA-RG2 PET ImagingRadiation
Intravenous injection of 1.8 MBq [0.05MCi]/kg of [68Ga]Ga-NOTA-RG2 in a single dose.
| Study group | Role | What they receive |
|---|---|---|
| patients with primary and/or metastatic hepatocellular carcinoma (HCC) | Experimental | The diagnosis of HCC is established by surgery or biopsy pathology. Receives: Radiation: [68Ga]Ga-NOTA-RG2 PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete PET imaging
To assess the sensitivity and specificity of diagnosing HCC using [68Ga]Ga-NOTA-RG2.
Measured: 90mins from time of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Jun 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiHui Guan, Huashan Hospital
- Investigators
- Fang Xie, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148155
- Sponsor's protocol ID
- KY2023-544
- Status last verified
- Feb 2024
- First submitted
- 19 Nov 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of [68Ga]Ga-NOTA-RG2 PET Imaging in the Diagnosis of Hepatocellular
- ClinicalTrials.gov ID
- NCT06148155
- Acronym / sponsor ID
- KY2023-544
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Positron-Emission Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 28 Nov 2023 (actual)
- 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 aim of this study was to establish and optimize the imaging method of [68Ga]Ga-NOTA-RG2, as well as its physiological and pathological distribution characteristics, and on this basis to evaluate the diagnostic efficacy of the above imaging agents in patients with hepatocellular carcinoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with primary and/or metastatic hepatocellular carcinoma (HCC) | Experimental | Radiation: [68Ga]Ga-NOTA-RG2 PET ImagingThe diagnosis of HCC is established by surgery or biopsy pathology. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hepatocellular carcinoma patients
Key exclusion criteria (7 listed)
- Subjects meeting any of the following criteria will be excluded from the study:
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 |
|---|---|---|
| [68Ga]Ga-NOTA-RG2 PET ImagingIntravenous injection of 1.8 MBq [0.05MCi]/kg of [68Ga]Ga-NOTA-RG2 in a single dose. | Radiation | patients with primary and/or metastatic hepatocellular carcinoma (HCC) |
Primary outcome
Complete PET imaging
Time frame: 90mins from time of injection
To assess the sensitivity and specificity of diagnosing HCC using [68Ga]Ga-NOTA-RG2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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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.
Fang Xie, PhD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-NOTA-RG2 PET Imaging in people with Hepatocellular Carcinoma, run by Huashan 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 6 inclusion and 7 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 16 Feb 2024. 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?
Contact Yihui Guan (+8613764308300, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete PET imaging (time frame: 90mins from time of injection). 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 16 Feb 2024.