A Study of 99mTc-3PRGD2 Injection in Lung Cancer Patient

Study Overview
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Brief Summary
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The study drug Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection（99mTc-3PRGD2） of this study is a novel radioactive diagnostic preparation for clinical use as a nuclear medicine molecular probe for tumor SPECT/CT imaging. After 99mTc-3PRGD2 is injected into the body, it is specifically taken up by integrin receptor-positive tumor tissue, and the image of tumor tissue can be obtained by SPECT/CT, This can be used for molecular imaging diagnosis and individualized treatment of common tumors. The primary objective of this study was to evaluate the efficacy of 99mTc-3PRGD2 for the diagnosis of lymph node metastasis in lung tumors. The minor objective was to evaluate the efficacy of 99mTc-3PRGD2 in the differential diagnosis of benign and malignant lung tumors and the safety of 99mTc-3PRGD2 in vivo of humans.

Detailed Description
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This study strictly obeyed to the result by pathological diagnoses standard. The evaluation of the efficacy of 99mTc-3PRGD2 in the diagnosis of lymph node metastasis of lung tumors is based on a multi-center, open, self-controlled clinical trial. This study involves 10 research sites and a total of about 400 qualified patients who met the protocol requirements in China, besides, they were previously diagnosed by 18F FDG PET / CT with positive results in pulmonary occupying and lymph nodes (hilar or mediastinum) uptake. At least 270 participants' surgical pathology report were required. After screening the patients, the intravenous injection of 99mTc-3PRGD2 with a dose of 0.3 mCi / kg was performed, followed by SPECT / CT plain scan and chest tomography scan. The doctors are responsible for patients about whether they should take lymphadenectomy and obtain the surgical pathology reports. At the same time, the safety of 99mTc-3PRGD2 injection in human body was evaluated. This study strictly obeyed to the result by pathological diagnoses standard which uses the four-grid table to calculate the accuracy, sensitivity and specificity of 99mTc-3PRGD2 SPECT/CT diagnosis. Besides, the diagnostic results of 18F-FDG Positron Emission computed Tomography/Chest Tomography (PET/CT) were compared to evaluate the effectiveness of 99mTc-3PRGD2 SPECT/CT in the diagnosis of lymph node metastasis and differential diagnosis of benign and malignant lung tumors as well as evaluate the safety of 99mTc-3PRGD2 injection in vivo of humans. This study invited an independent imaging evaluation committee to evaluate images obtained with 18F-FDG PET/CT, 99mTc-3PRGD2 SPECT/CT and enhanced CT. Study duration: The start of the study is defined as the date on which the first participant signed the Informed Consent Form (ICF); the End Of the Study (EOS) was defined as the end of the collection of the final participant safety assessment data.

Official Title
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An Evaluation of the Efficacy and Safety of Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection in a Multicenter, Open, Self-controlled Clinical Trial for the Lymph Node Metastasis in Lung Tumors

Conditions
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Lung Cancer Metastatic

Intervention / Treatment
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* Drug: 99mTc-3PRGD2


Participation Criteria
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Eligibility Criteria
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Requirements for participants: Patients only meet all the following requirements are qualified to this study Voluntarily participate in and sign the ICF. Age older than (or equal to) 18 years. Lung solid nodules with the longest diameter ≥ 1.5cm, shortest diameter ≥ 1.0 cm (diagnosed by CT) and scheduled for surgical resection. Patients after 18F-FDG PET / CT examination with the positive results in pulmonary space occupying and lymph node (hilar or mediastinal) uptake. Willing and able to follow the visit schedule, dosing plan, various checks. Clinical laboratory tests and other indicators are in the normal range or not but do not affect the relevant examination and treatment. Patients cannot be enrolled as long as they match one of them: Patients meet any one of the following requirements are exclusive to this study: Female patients who are preparing for pregnancy within 6 months or are in pregnancy or lactation Allergic to test drugs, allergies or allergies to multiple drugs The results of enhanced CT examination are non-solid component ground glassy nodules. Fasting blood glucose levels above 7.0 mmol/L before injection of 18F-FDG (fast glucose meter test) Bodyweight is more than 100 kg Claustrophobia patients Patients cannot tolerate two arms up and lie for 15 30 minutes The investigator believes that it is not appropriate to participate in this clinical trial. Those who have participated in clinical trials or are participating in other clinical trials in the past month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTc-3PRGD2<br>Volunteers were injected intravenously and then scanned by SPECT/CT. Drugs use generic name：Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection dosage form:Injection dosage:0.3mCi/kg frequency:single dose | Drug: 99mTc-3PRGD2<br>* Volunteers were injected intravenously and then scanned by SPECT/CT. Drugs use generic name：Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection dosage form:Injection dosage:0.3mCi/kg<br>* Other names: Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of diagnostic efficacy of 99mTc-3PRGD2 for lymph node metastasis of lung tumors | The study results are strictly according to pathological diagnoses standard when evaluating whether the efficacy of 99mTc-3PRGD2 in the diagnosis of lymph node metastasis of lung tumors is superior to 18F-FDG PET/CT. | post-intervention at 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy and sensitivity of 99mTc-3PRGD2 for diagnostic efficacy of lymph node metastasis in lung cancer | The study results are strictly according to pathological diagnoses standard when evaluating the accuracy and sensitivity of 99mTc 3PRGD2 SPECT/CT by comparing to the enhanced CT for the diagnosis of lymph node metastasis of lung tumors. | post-intervention at 10 months | 
| Accuracy, sensitivity and specificity of 99mTc-3PRGD2 for diagnostic efficacy of benign and malignant lung tumors | The study results are strictly according to pathological diagnoses standard when evaluating the accuracy, sensitivity and specificity of 99mTc 3PRGD2 SPECT/CT by comparing to enhanced CT for the diagnosis of lymph node metastasis of lung tumors. | post-intervention at 10 months | 
| Accuracy, sensitivity and specificity of 99mTc-3PRGD2 for diagnostic efficacy of pulmonary lymph node metastasis | The study results are strictly according to pathological diagnoses standard when evaluating the accuracy, sensitivity and specificity of 99mTc 3PRGD2 SPECT/CT by comparing to enhanced CT for the diagnosis of lymph node metastasis of lung tumors. | post-intervention at 10 months | 
| Accuracy, sensitivity and specificity of 99mTc-3PRGD2 for diagnostic efficacy of benign and malignant lung tumors | The study results are strictly according to pathological diagnoses standard when evaluating the accuracy, sensitivity and specificity of 99mTc 3PRGD2 SPECT/CT by comparing to enhanced CT for the differential diagnosis of benign and malignant lung tumors. | post-intervention at 10 months | 
| Incidence of adverse events | Evaluating the safety of 99mTc 3PRGD2 SPECT/CT in vivo of humans. | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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99mTc-3PRGD2, Integrin ανβ3;, lung cancer