PET Imaging of 68Ga-NOTA-H006 in Malignancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg..
- Who it may be relevant to
- Registry conditions: Tumor, Solid. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study to Evaluate 5T4 Expression in Malignant Tumors Using 68Ga-NOTA-H006
Overview
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.
Interventions
- Drug 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
Primary outcome measures
- Establishment and optimization of imaging method for 68Ga-NOTA-H006 PET [Time frame: 90mins from time of injection]
Eligibility criteria
Inclusion criteria
- 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:
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Huashan Hospital — Shanghai
Identifiers
NCT: NCT06162988 · KY2023-777