Clinical trial NCT02744729: 99mTc-3PRGD2 SPECT/CT in Esophagus Cancer Patients
Official title: Safety and Diagnostic Performance of 99mTc-3PRGD2 SPECT/CT in Esophagus Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Esophageal Cancer
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label single photon emission computed tomography / computed tomography (SPECT/CT) study to investigate the safety and diagnostic performance of 99mTc-HYNIC-3PEG4-E\[c(RGDfK)2) (99mTc-3PRGD2) in esophagus cancer patients. A single dose of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion of esophagus cancer. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients.

Detailed description: Integrin αvβ3 is an important member of integrin receptor family and expressed preferentially on the activated endothelial cells of angiogenesis and some types of tumor cells, but not or very low on the quiescent vessel cells and other normal cells. Therefore, the integrin αvβ3 receptor is becoming a valuable target for diagnosis and response evaluation of malignant tumors.

The tri-peptide sequence of arginine-glycine-aspartic acid (RGD) can specifically bind to the integrin αvβ3 receptor. Accordingly, a variety of radiolabeled RGD-based peptides have been developed for non-invasive imaging of integrin αvβ3 expression via single photon emission computed tomography (SPECT)or positron emission tomography (PET). Among all the RGD radiotracers studied, several RGD monomers have been investigated in clinical trials, and the preliminary results demonstrated specific imaging of various types of tumors, and the tumor uptake correlated well with the level of integrin αvβ3 expression. Recently, several RGD dimeric peptides with PEG linkers have been studied. The new types of RGD peptides showed much higher in vitro integrin αvβ3-binding affinity than the single RGD tri-peptide sequence, and importantly, they exhibited significantly increased tumor uptake and improved in vivo kinetics in animal models. As a representative, 99mTc-3PRGD2 could be easily prepared and exhibited excellent in vivo behaviors in animal models. No adverse reactions are observed in animal models to date.

For the further interests in clinical translation of 99mTc-3PRGD2, an open-label SPECT/CT study was designed to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in esophagus cancer patients. A single dose of nearly 11.1 MBq/kg body weight 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the esophagus cancer patients. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Adverse events will also be observed in the patients.

Eligibility criteria: Inclusion Criteria:

* Males and females, ≥30 years old
* Thoracic CT and/or gastroscopy diagnosis in suspicion of primary or recurrent lung cancer.
* The lung cancer will be histologically confirmed or results of histology will be available.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential
* Known severe allergy or hypersensitivity to IV radiographic contrast.
* Inability to lie still for the entire imaging time because of cough, pain, etc.
* Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.

Primary outcomes:
measure: Visual Assessment of Esophagus Lesions in 99mTc-3PRGD2 SPECT/CT Scan
timeFrame: one year
measure: Semiquantitative Assessment of Esophagus Lesions in 99mTc-3PRGD2 SPECT/CT Scan
timeFrame: one year
Secondary outcomes:
measure: 18F-FDG PET/CT Scan
timeFrame: one year
measure: Laboratory Values
timeFrame: one year
measure: Adverse events collection
timeFrame: 5 days
measure: Contrast-enhanced CT
timeFrame: one year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Weibing Miao, MD
role: STUDY_DIRECTOR
References: