PET Imaging of 68Ga-NOTA-H006 in Malignancy

ConditionTumor, Solid

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorYiHui Guan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Patients who underwent 68Ga-NOTA-H006 and 18F-FDG PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

90mins from time of injection

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

YiHui Guan

Lead sponsor

Huashan Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: