Tumor, SolidNCT06162988
PET Imaging of 68Ga-NOTA-H006 in Malignancy
A study testing 68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg. in people with Tumor, Solid, run by YiHui Guan at 1 site in China.
Trial summary
5T4, also known as trophoblast glycoprotein, is an oncofoetal antigen expressing in fetal development and cancer but rarely in adult. The high expression of 5T4 in malignancy was found be associated with poor clinical outcomes in ovarian, gastric and colorectal cancers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- 68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Dec 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pancreatic cancer clinical trial study subjects must meet all of the following criteria:
- Age between 18 and 65 years old.
- Pancreatic occupancy is found on imaging and combined with clinical judgment as a patient with pancreatic cancer.
- Written informed consent signed by the subject or his/her legal guardian or caregiver.
- Willingness and ability to cooperate with all programs of the study.
- Lung cancer clinical trial study subjects must meet all of the following criteria:
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- Be between the ages of 18 and 65 years old.
- Patients with CT findings of suspicious space on the lungs with a diameter of more than 1cm who have not undergone surgery.
- 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.
- Bowel cancer clinical trial study subjects must meet all of the following criteria:
- Be between the ages of 18 and 65.
- Have a clear histologic or pathologic diagnosis of colorectal cancer.
- Written informed consent signed by the subject or legal guardian or caregiver.
- Willingness and ability to cooperate with all programs of this study.
Who cannot join
- Severe hepatic or renal insufficiency;
- Targeted therapy prior to radiotherapy or PET/CT scan. 5T4 expression in existing lesions assessed by immunohistochemistry using antibody clones.
- History of serious surgery in the last month.
- Those who have participated in other clinical trials during the same period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huashan Hospital
Shanghai, 200040
Yihui Guan, +8613764308300, guanyihui@hotmail.com
About this study
Official title: A Study to Evaluate 5T4 Expression in Malignant Tumors Using 68Ga-NOTA-H006
5T4, also known as trophoblast glycoprotein, is an oncofoetal antigen expressing in fetal development and cancer but rarely in adult. The high expression of 5T4 in malignancy was found be associated with poor clinical outcomes in ovarian, gastric and colorectal cancers. Several antibody drug conjugates are currently under development for cancer therapy in preclinic and clinic stages.
Previously, investigators engineered a 5T4-specific biomolecule with nanomolar binding affinity. Radiolabeling with gallium-68 resulted in 68Ga-NOTA-H006 which showed 5T4 expression in a variety of xenograft models. Thus, the aims of current study are to evaluate the distribution and dosimetry of this novel tracer, and to explore the diagnostic values of 68Ga-NOTA-H006 in malignant tumors.
- Conditions
- Tumor, Solid
- Being tested
- 68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg.Drug
68Ga-NOTA-H006：PET imaging； 18F-FDG：PET imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent 68Ga-NOTA-H006 and 18F-FDG PET/CT | Experimental | 68Ga-NOTA-H006, single dose Receives: Drug: 68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment and optimization of imaging method for 68Ga-NOTA-H006 PET
Analyze the standardized uptake value (SUV) of 68Ga-NOTA-H006 on the lesions Compare the SUV with 5T4 expression in pathological specimens
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 posted8 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YiHui Guan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YiHui Guan, Huashan Hospital
- Investigators
- Fang Xie, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162988
- Sponsor's protocol ID
- KY2023-777
- Status last verified
- Dec 2023
- First submitted
- 19 Nov 2023
- Last updated
- 8 Dec 2023
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate 5T4 Expression in Malignant Tumors Using 68Ga-NOTA-H006
- ClinicalTrials.gov ID
- NCT06162988
- Acronym / sponsor ID
- KY2023-777
- Conditions
- Tumor, Solid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- YiHui GuanUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Dec 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.
5T4, also known as trophoblast glycoprotein, is an oncofoetal antigen expressing in fetal development and cancer but rarely in adult. The high expression of 5T4 in malignancy was found be associated with poor clinical outcomes in ovarian, gastric and colorectal cancers. Several antibody drug conjugates are currently under development for cancer therapy in preclinic and clinic stages.
Previously, investigators engineered a 5T4-specific biomolecule with nanomolar binding affinity. Radiolabeling with gallium-68 resulted in 68Ga-NOTA-H006 which showed 5T4 expression in a variety of xenograft models. Thus, the aims of current study are to evaluate the distribution and dosimetry of this novel tracer, and to explore the diagnostic values of 68Ga-NOTA-H006 in malignant tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent 68Ga-NOTA-H006 and 18F-FDG PET/CT | Experimental | Drug: 68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg.68Ga-NOTA-H006, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pancreatic cancer clinical trial study subjects must meet all of the following criteria:
- Be between the ages of 18 and 65 years old.
- Patients with CT findings of suspicious space on the lungs with a diameter of more than 1cm who have not undergone surgery.
- 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.
Key exclusion criteria (4 listed)
- Severe hepatic or renal insufficiency;
- Targeted therapy prior to radiotherapy or PET/CT scan. 5T4 expression in existing lesions assessed by immunohistochemistry using antibody clones.
- History of serious surgery in the last month.
- Those who have participated in other clinical trials during the same period.
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-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg.68Ga-NOTA-H006：PET imaging； 18F-FDG：PET imaging | Drug | Patients who underwent 68Ga-NOTA-H006 and 18F-FDG PET/CT |
Primary outcome
Establishment and optimization of imaging method for 68Ga-NOTA-H006 PET
Time frame: 90mins from time of injection
Analyze the standardized uptake value (SUV) of 68Ga-NOTA-H006 on the lesions Compare the SUV with 5T4 expression in pathological specimens
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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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.
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-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg. in people with Tumor, Solid, run by YiHui Guan 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 15 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: opening soon, as of the sponsor's last update on 8 Dec 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yihui Guan, MD (13764308300 ext. +86, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment and optimization of imaging method for 68Ga-NOTA-H006 PET (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 8 Dec 2023; AzTrials last refreshed its copy on 26 Oct 2026.