99mTc-3PRGD2 SPECT/CT for Integrin Imaging of Lung Cancer

NCT04233476 | Completed Phase 3 DMC

• 1 other identifier: FSRDA201901
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 11

Brief Summary

This is a prospective, multicenter, self-controlled phase 3 clinical trial designed to evaluate the safety and efficacy of an integrin αVβ3-targeted imaging, 99mTc-3PRGD2 SPECT/CT, for diagnosis of lung cancer and mapping the lymph node metastases. The pathological results will be considered as the gold standard and the conventional metabolic imaging by 18F-FDG PET/CT will be used for a head-to-head comparison. The primary objective of this study is to evaluate the efficacy of 99mTc-3PRGD2 SPECT/CT in mapping of lymph node metastasis according to the nodal mapping system released by the International Association for the Study of Lung Cancer in 2009 (IASLC-2009). The secondary objectives include evaluation of 99mTc-3PRGD2 SPECT/CT in detection of lung cancer and the safety of 99mTc-3PRGD2 injection in human beings.

Conditions

Lung Cancer; Lymph Node Metastasis

Keywords

99mTc-3PRGD2; Integrin ανβ3; lung cancer; lymph node metastasis

Outcome Measures

Primary Outcomes (1)

• Evaluate whether the diagnostic specicity of 99mTc-3PRGD2 SPECT/CT is superior to that of 18F-FDG PET/CT in mapping lymph node metastasis of lung cancer in the same group of patients.

  Using the pathological results as the gold standard, calculate the specificity of 99mTc-3PRGD2 SPECT/CT in mapping of lymph node metastasis of lung cancer according to the nodal mapping system released by the International Association for the Study of Lung Cancer in 2009 (IASLC-2009), and compared it head-by-head with that of the conventional metabolic imaging by 18F-FDG PET/CT in the same group of patients. And then assess if the specificity of 99mTc-3PRGD2 SPECT/CT is superior to that of 18F-FDG PET/CT.

  From the informed consent of the first participant to 2 weeks after the intervention of the last participants or until the last participant accepted surgery within 2 weeks

Secondary Outcomes (3)

• Diagnostic accuracy, sensitivity, positive predictive value and negative predicive value of 99mTc-3PRGD2 SPECT/CT in mapping lymph node metastasis of lung cancer, with a head-to-head comparison to 18F-FDG PET/CT.

  From the informed consent of the first participant to 2 weeks after the intervention of the last participants or until the last participant accepted surgery within 2 weeks

• Efficacy of 99mTc-3PRGD2 SPECT/CT in diagnosis of lung cancer, with a head-to-head comparison to 18F-FDG PET/CT.

  From the informed consent of the first participant to 2 weeks after the intervention of the last participants or until the last participant accepted surgery within 2 weeks

• Incidence of adverse events for safety evaluation of 99mTc-3PRGD2 injection and SPECT/CT imaging in human beings

  From the informed consent of the first participant to 2 weeks after the intervention of the last participants or until the last participant accepted surgery within 2 weeks

Study Arms (1)

99mTc-3PRGD2 injection for SPECT/CT imaging, with 18F-FDG PET/CT for head-to-head comparison.

EXPERIMENTAL

Participants will receive a single-dose intravenous injection of 99mTc-3PRGD2 at a dosage of approximate 11.10 MBq (0.30 mCi) per kilogram body weight. Whole-body planar scan and chest SPECT/CT imaging will be performed 40-50 min later. Chest low-dose spiral CT (120 kV, 50 mAs) will be used for attenuation correction and anatomical localization. The conventional metabolic imaging by 18F-FDG PET/CT of the same patients within one week will be used for a self-controlled head-to-head comparison.

Drug: 99mTc-3PRGD2 injection

Interventions

99mTc-3PRGD2 injection DRUG

A diagnostic drug targeting integrin αvβ3, technetium-99m \[99mTc\] labeled hydrazinonicotinamide-PEG4-E\[PEG4-c(RGDfk)\]2 (99mTc-3PRGD2), will be intravenously injected to the participants for imaging of lung cancer and mapping lymph node metastasis via single photon emission computed tomography/ X-ray computed tomography (SPECT/CT) .

Also known as: Technetium-99m [99mTc] labeled hydrazinonicotinamide-PEG4-E[PEG4-c(RGDfk)]2

99mTc-3PRGD2 injection for SPECT/CT imaging, with 18F-FDG PET/CT for head-to-head comparison.

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate and sign the Informed Consent Form;
• Age ≥18 years old;
• Diagnostic CT shows that the longest diameter of the tumor occupying the lung is ≥1.5 cm and the shortest diameter is ≥1.0 cm;
• F-FDG PET/CT examination shows tumor occupancy in the lungs, with positive hilar and/or mediastinal lymph nodes on either enhanced CT or 18F-FDG PET/CT;
• Willing and be able to follow scheduled visits, treatment plans, and laboratory tests;
• Clinical laboratory examination and other indicators are within the normal range or abnormal but do not affect related examinations and treatments.

You may not qualify if:

• Patients who have any of the following are not eligible for enrollment:
• Female patients who plan of pregnant within 6 months, or in pregnant or lactating;
• Allergic to the test drugs, have allergic constitution, or are allergic to multiple drugs;
• Contrast-enhanced CT examination shows ground-glass nodules without solid components;
• Before injecting 18F-FDG, the fasting blood glucose level exceeds 7.0 mmol/L (tested by rapid blood glucose meter);
• Body weight exceeds 100 kg;
• With claustrophobia;
• Cannot tolerate raising their arms and lying on the scanner bed for 15-30 min;
• Those the investigator believes not suitable to participate in this clinical trial;
• Those who are currently participating in another clinical trial or have participated in other clinical trials within the past 3 month.

Sponsors & Collaborators

• RDO Pharm.: lead
• Beijing Pharbers Genesis Pharmaceutical Technology Co., Ltd.: collaborator

Study Sites (11)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510062, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010050, China

Location

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130032, China

Location

Shengjing Hospital of China Medical University

Shengyang, Liaoning, 110022, China

Location

Renji Hospital of Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200001, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

First Hospital of Shanxi Medical Universit

Taiyuan, Shanxi, 030001, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Lymphatic Metastasis

Interventions

Technetium

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals

Study Officials

• Zhaohui Zhu, MD, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: October 12, 2019
• Primary Completion: May 8, 2021
• Study Completion: May 8, 2021
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)