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

August 6, 2020 updated by: Fifth Affiliated Hospital, Sun Yat-Sen University

The Efficacy of 99mTc-3PRGD2 SPECT/CT Imaging in the Diagnosis of Lymph Node Metastasis of Esophageal Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • The Fifth Affiliated Hospital of Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 99mTc-3PRGD2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the accuracy of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis
Time Frame: 14 days
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
Time Frame: 14 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Incidence of Adverse Events
Time Frame: 14 days
To evaluate the safety of 99mTc-3PRGD2 in SPECT/CT in the diagnosis of lymph node metastasis of esophageal carcinoma
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborators

Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIC-ESO-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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