PET Imaging of 68Ga-NOTA-H006 in Malignancy

YiHui Guan

Status: Not yet enrolling

Conditions: Tumor, Solid

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06162988

KY2023-777

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

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

Experimental group

Description:

68Ga-NOTA-H006, single dose

Treatment:

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