An interventional study of 99mTc-3PRGD2 in Esophageal Cancer, Lymph Node Metastases and Diagnoses Disease, sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-07.
Sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Diagnostic
The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China, which become a severe challenge for public health. The molecular imaging technology has been developed for visualization and precise diagnosis of the tumors. Integrin αvβ3 is a specific marker for tumor. Noninvasive visualization and quantitative analysis of integrin αvβ3 expression provide new opportunities for tumor diagnosis, identification and efficacy monitoring. The peptide containing Arg-Gly-Asp (RGD) can specifically bind to integrin αvβ3 receptor with high selectivity and affinity to achieve the detecting tumor .The SPECT/CT with 99mTc-3PRGD2 has a high specificity in the diagnosis of mediastinal lymphnode metastasis and a greater value in the decision-making of lymphnode dissection.
This study is a single-center self-controlled study, It is planned to enroll 30 patients with esophageal cancer , preliminarily confirmed by endoscopic biopsy, . After intravenous injection of 0.3 mCi/kg of 99mTC-3PRGD2, patients underwent single-photon emission computed tomography/computed tomography (SPECT/CT) examination.Subsequently, the patients received chest/abdomen enhanced CT and 18F fluorodeoxyglucose (18F-FDG) positron emission computed tomography /CT (PET/CT) for diagnosis. According to the determination of the researcher, patients who were suitable for surgery received surgery to obtain surgical pathology; For patients who were not suitable for surgery, ultrasound-guided lyphnode biop was performed .In this study, pathological specimens were obtained from gastroscopy, surgical pathology, or ultrasound-guided lymph node biopsy. The diagnostic accuracy, sensitivity , specificity and safety of SPECT/CT with 99mTc-3PRGD2 were evaluated and compared with PET-CT and enhanced CT.
Screening period All patients will be during the screening screening assessment, specific include: the signing of the ICF, demographic data, drug allergy history and history, height, weight, physical examination, vital signs, electrocardiogram (ECG) examination, laboratory examination, blood pregnancy test records (if applicable), endoscopic biopsy, AE and drug combination, check into/standard. Qualified patients will enter the administration period after screening and confirmation. Administration period (from Administration to safety follow-up) day of administration (study day 1): before administration of the experimental drug, 12-lead ECG, laboratory test (fasting) and vital signs were measured. Subsequently, the experimental drug was injected intravenously at 0.3 ± 20% mCi/kg, and subjects underwent urination and SPECT/CT examination 40 min after administration. AE and combined medication were recorded. The next day after administration (day 2 of the study): 12-lead ECG, laboratory examination (fasting), vital signs were measured, AE and combined medication were recorded. Between the administration of 99mTc-3PRGD2 and the safety follow-up, the investigator determined that chest/abdomen enhanced CT and PET/CT were performed at an optional date.
Safety follow-up (day 14±2 of the study or before the next clinical intervention, whichever is shorter) :
12 lead ECG, laboratory test (fasting), measurement of vital signs, blood pregnancy (women of childbearing age only), AE and combined medication were recorded.Lymph node histopathology was obtained by surgery in patients suitable for surgery, and by ultrasound-guided lymph node biopsy in patients unsuitable for surgery.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 30 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Fifth Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 57 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
intravenous injection of 0.3 mCi/kg of 99mTC-3PRGD2, patients underwent single-photon emission computed tomography/COMPUTED tomography (SPECT/CT) examination.
Diagnostic Test: 99mTc-3PRGD2
intravenous injection of 0.3 mCi/kg of 99mTc-3PRGD2
the accuracy of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis
To evaluate the accuracy of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis of esophageal carcinoma，according to the pathological analysis, according to the pathological analysis.
Time frame: 14 days
the sensitivity of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis
To evaluate the sensitivity of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis of esophageal carcinoma，according to the pathological analysis, compared with PET-CT and enhanced CT.
Time frame: 14 days
The Incidence of Adverse Events
To evaluate the safety of 99mTc-3PRGD2 in SPECT/CT in the diagnosis of lymph node metastasis of esophageal carcinoma
Time frame: 14 days
Plan to share: No
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Fifth Affiliated Hospital, Sun Yat-Sen University