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

• Status: Recruiting
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RDO Pharm.
• Collaborator: Beijing Pharbers Genesis Pharmaceutical Technology Co., Ltd.
• Treatments: Arginyl-glycyl-aspartic acid

Criteria

Requirements for participants:

Patients only meet all the following requirements are qualified to this study

1. Voluntarily participate in and sign the ICF.

2. Age older than (or equal to) 18 years.

3. Lung solid nodules with the longest diameter ≥ 1.5cm, shortest diameter ≥ 1.0 cm (diagnosed by CT) and scheduled for surgical resection.

4. Patients after 18F-FDG PET / CT examination with the positive results in pulmonary space occupying and lymph node (hilar or mediastinal) uptake.

5. Willing and able to follow the visit schedule, dosing plan, various checks.

6. 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:

1. Female patients who are preparing for pregnancy within 6 months or are in pregnancy or lactation

2. Allergic to test drugs, allergies or allergies to multiple drugs

3. The results of enhanced CT examination are non-solid component ground glassy nodules.

4. Fasting blood glucose levels above 7.0 mmol/L before injection of 18F-FDG (fast glucose meter test)

5. Bodyweight is more than 100 kg

6. Claustrophobia patients

7. Patients cannot tolerate two arms up and lie for 15~30 minutes

8. The investigator believes that it is not appropriate to participate in this clinical trial.

9. Those who have participated in clinical trials or are participating in other clinical trials in the past month.