PET Imaging of 68Ga-NOTA-H006 in Malignancy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tumor, Solid
• Intervention / Treatment: Drug: 68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yihui Guan, MD; Phone Number: +86 13764308300; Email: guanyihui@hotmail.com

Study Locations

• China
  • Shanghai, China, 200040
    • Huashan Hospital
    • Contact: Yihui Guan; Phone Number: +8613764308300; Email: guanyihui@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients who underwent 68Ga-NOTA-H006 and 18F-FDG PET/CT; 68Ga-NOTA-H006, single dose	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: YiHui Guan
• Investigators: Principal Investigator: Fang Xie, PhD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KY2023-777

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No