Comparative analysis of the single photon diagnostic tecnology (Spect/CT), with radiopharmaceutical application of Ecdg-99mTc , and computed tomography (CT)- in patients with Lung Cancer.

Phase 3

• Conditions: Malignant neoplasm of trachea, bronchus and lung / Neoplasia Solida

• Registration Number: RBR-2qpsxw
• Lead Sponsor: Esho Empresa de serviços hospitalares S.A. – Hospital Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Male or female subject with at least 18 years of age. Women may not be pregnant or breast-feeding, and, for those in post-menopausal, the minimum period shall be 12 months for natural process, or 6 months in surgical cases. Agree to adhere to one of the birth control methods (contraceptives) as proposed protocol. Have evidence of lung cancer or CT study results consistent with a diagnosis of lung cancer. Not be receiving cancer treatment (surgery, radiotherapy and / or chemotherapy) or if the person has had lung cancer in the past, all previous therapy should have completed at least 3 months prior to the inclusion in the study. Must have a score in the instrument Eastern Cooperative Oncology Group (ECOG) less than or equal to 2. Present satisfactory laboratory values (l alanine aminotransferase less than or equal to 2.5 x ULN, aspartate aminotransferase less than or equal to 2.5 x ULN; less than or equal to 2.5 x ULN; bilirubin less than or equal to 2.0 x ULN)

Exclusion Criteria

If there are any clinically relevant safety concerns (laboratory, ECG, physical examination, other) which, in the opinion of the investigator, put the subject in unnecessary risk if the subject were to participate. If, in the last 3 months, the patient has been submitted to any treatment for Cancer (radiation therapy, surgery or chemotherapy). Diabetic patient with insulin dependency. Weight limit higher than recommended by SPECT / CT and CT table. Known hypersensitivity to ECDG or contrast, or other compound, including any of the inactive ingredients. Pregnancy or suspected pregnancy, lactation, or planned pregnancy (male and female partners). Clinically significant mental illness that compromises the conduct of the study (which should be determined by the investigator).

Study & Design

• Study Type: Intervention
• Study Design: Not specified