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PET Imaging of 68Ga-NOTA-H006 in Malignancy

NCT ID: NCT06162988

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tumor, Solid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

68Ga-NOTA-H006, single dose

Group Type EXPERIMENTAL

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

Intervention Type DRUG

68Ga-NOTA-H006：PET imaging； 18F-FDG：PET imaging

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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YiHui Guan

OTHER

Sponsor Role lead

Responsible Party

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YiHui Guan

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fang Xie, PhD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

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Huashan Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Yihui Guan, MD

Role: CONTACT

Phone: 13764308300

Email: [email protected]

Facility Contacts

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Yihui Guan

Role: primary

Other Identifiers

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KY2023-777

Identifier Type: -

Identifier Source: org_study_id