PET Imaging of 68Ga-NOTA-H006 in Malignancy

NCT06162988 | Not Yet Recruiting DMC

• 1 other identifier: KY2023-777
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor, Solid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients who underwent 68Ga-NOTA-H006 and 18F-FDG PET/CT

EXPERIMENTAL

68Ga-NOTA-H006, single dose

Drug: 68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg.

Interventions

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

Patients who underwent 68Ga-NOTA-H006 and 18F-FDG PET/CT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• YiHui Guan: lead

Study Sites (1)

Huashan Hospital

Shanghai, 200040, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Fang Xie, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan, MD

CONTACT

13764308300; guanyihui@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

CN (1)