99m Tc-3PRGD2 SPECT/CT Imaging in the Diagnosis of Lymph Node Metastasis of Esophageal Carcinoma

NCT04504565 | Unknown DMC

• 1 other identifier: MIC-ESO-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer; Lymph Node Metastases; Diagnoses Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  14 days

Secondary Outcomes (1)

• The Incidence of Adverse Events

  14 days

Study Arms (1)

99mTc-3PRGD2

EXPERIMENTAL

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

Interventions

99mTc-3PRGD2 DIAGNOSTIC_TEST

intravenous injection of 0.3 mCi/kg of 99mTc-3PRGD2

99mTc-3PRGD2

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Esophageal cancer was confirmed by Endoscopic biopsy
• Clinical laboratory tests (heart, liver, kidney, blood) and other indicators are in the normal range, or the abnormalities have no clinical significance (NCS), or the abnormalities have clinical significance (CS) but do not affect the implementation of surgery or lymph node puncture;
• The patient being able to follow scheduled visits, treatment plans and laboratory tests.

You may not qualify if:

• Female patients who plan to become pregnant within 6 months, or are pregnant or breastfeeding;
• Allergic to test drugs, allergic constitution or multiple drugs;
• Weight over 100 kg;
• Claustrophobia;
• Cannot tolerate both arms raised and supine for 15-30 minutes;
• The investigator considers it inappropriate to participate in this clinical trial;
• The patient participated in or participating in other clinical trials within the past 3 months.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead
• Peking University: collaborator

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

Related Publications (8)

• Zhang Z, Zhao X, Ding C, Wang J, Zhang J, Wang F. (99m)Tc-3PRGD2 SPECT/CT Imaging for Monitoring Early Response of EGFR-TKIs Therapy in Patients with Advanced-Stage Lung Adenocarcinoma. Cancer Biother Radiopharm. 2016 Sep;31(7):238-45. doi: 10.1089/cbr.2016.2052. Epub 2016 Aug 26.

  PMID: 27563805 RESULT

• Jin X, Liang N, Wang M, Meng Y, Jia B, Shi X, Li S, Luo J, Luo Y, Cui Q, Zheng K, Liu Z, Shi J, Li F, Wang F, Zhu Z. Integrin Imaging with 99mTc-3PRGD2 SPECT/CT Shows High Specificity in the Diagnosis of Lymph Node Metastasis from Non-Small Cell Lung Cancer. Radiology. 2016 Dec;281(3):958-966. doi: 10.1148/radiol.2016150813. Epub 2016 Jul 29.

  PMID: 27479638 RESULT

• Ji B, Chen B, Wang T, Song Y, Chen M, Ji T, Wang X, Gao S, Ma Q. (9)(9)mTc-3PRGD(2) SPECT to monitor early response to neoadjuvant chemotherapy in stage II and III breast cancer. Eur J Nucl Med Mol Imaging. 2015 Aug;42(9):1362-70. doi: 10.1007/s00259-015-3062-1. Epub 2015 May 7.

  PMID: 25947573 RESULT

• Ma Q, Min K, Wang T, Chen B, Wen Q, Wang F, Ji T, Gao S. (99m)Tc-3PRGD 2 SPECT/CT predicts the outcome of advanced nonsquamous non-small cell lung cancer receiving chemoradiotherapy plus bevacizumab. Ann Nucl Med. 2015 Jul;29(6):519-27. doi: 10.1007/s12149-015-0975-5. Epub 2015 Apr 25.

  PMID: 25911312 RESULT

• Ma Q, Chen B, Gao S, Ji T, Wen Q, Song Y, Zhu L, Xu Z, Liu L. 99mTc-3P4-RGD2 scintimammography in the assessment of breast lesions: comparative study with 99mTc-MIBI. PLoS One. 2014 Sep 24;9(9):e108349. doi: 10.1371/journal.pone.0108349. eCollection 2014.

  PMID: 25250628 RESULT

• Liu L, Song Y, Gao S, Ji T, Zhang H, Ji B, Chen B, Jia B, Wang F, Xu Z, Ma Q. (99)mTc-3PRGD2 scintimammography in palpable and nonpalpable breast lesions. Mol Imaging. 2014;13(5). doi: 10.2310/7290.2014.00010.

  PMID: 24825112 RESULT

• Ma Q, Ji B, Jia B, Gao S, Ji T, Wang X, Han Z, Zhao G. Differential diagnosis of solitary pulmonary nodules using (9)(9)mTc-3P(4)-RGD(2) scintigraphy. Eur J Nucl Med Mol Imaging. 2011 Dec;38(12):2145-52. doi: 10.1007/s00259-011-1901-2. Epub 2011 Aug 27.

  PMID: 21874323 RESULT

• Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

  PMID: 26808342 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hong Shan, PhD

CONTACT

+86-18826913336; shanhong@mail.sysu.edu.cn

Xiaojin Wang, Master

CONTACT

+86-13798967219; wangxj55@mail.sysu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 7, 2020
• Study Start: August 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)