PET Imaging of 68Ga-NOTA-H006 in Malignancy

Tumor, Solid Clinical Trial

Official title:

A Study to Evaluate 5T4 Expression in Malignant Tumors Using 68Ga-NOTA-H006

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06162988
• Other study ID #: KY2023-777
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2028

Study information

• Verified date: December 2023
• Source: Huashan Hospital
• Contact: Yihui Guan, MD
• Phone: 13764308300
• Email: guanyihui[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2028
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Pancreatic cancer clinical trial study subjects must meet all of the following criteria:

1. Age between 18 and 65 years old.

2. Pancreatic occupancy is found on imaging and combined with clinical judgment as a patient with pancreatic cancer.

3. Written informed consent signed by the subject or his/her legal guardian or caregiver.

4. Willingness and ability to cooperate with all programs of the study.

Lung cancer clinical trial study subjects must meet all of the following criteria:

1. Be between the ages of 18 and 65 years old.

2. Patients with CT findings of suspicious space on the lungs with a diameter of more than 1cm who have not undergone surgery.

3. Written informed consent must be signed by the subject or his/her legal guardian or caregiver.

4. Willingness and ability to cooperate with all programs of the study.

Bowel cancer clinical trial study subjects must meet all of the following criteria:

1. Be between the ages of 18 and 65.

2. Have a clear histologic or pathologic diagnosis of colorectal cancer.

3. Written informed consent signed by the subject or legal guardian or caregiver.

4. Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

1. Severe hepatic or renal insufficiency;

2. Targeted therapy prior to radiotherapy or PET/CT scan. 5T4 expression in existing lesions assessed by immunohistochemistry using antibody clones.

3. History of serious surgery in the last month.

4. Those who have participated in other clinical trials during the same period.

Related Conditions & MeSH terms

• Tumor, Solid

Intervention

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

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
YiHui Guan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90mins from time of injection