Extensive Staging in Lung Cancer

NCT02030444 | Terminated

• 1 other identifier: ExtStaging-2014.1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this study is to compare standard staging of lung cancer (which includes clinical examination, CT, MRI, bone scan and PET-CT) with comprehensive staging - which includes the new staging methods (PET-MRI and systematic mapping of mediastinal and hilar lymph nodes using endobronchial ultrasound) with respect to disease stage and outcomes of therapy.

Conditions

Lung Neoplasms

Keywords

Neoplasms Staging; Bronchoscopy; Nuclear Medicine; Radiology

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression free survival in one year

Study Arms (2)

Standard diagnostic work-up

NO INTERVENTION

All patients will undergo todays' standard work-up (examination for diagnosing and staging) of lung cancer. This will be individualized for each patient according to current guidelines.

Extensive diagnostic work-up

EXPERIMENTAL

All patients will in addition to standard diagnostic work-up undergo PET-MRI and systematic mediastinal and hilar lymph node mapping using EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration of lymph nodes).

Procedure: PET-MRI and EBUS-TBNA

Interventions

PET-MRI and EBUS-TBNA PROCEDURE

Extensive diagnostic work-up

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

1. Patients undergoing examinations on suspicion of lung cancer (both SCLC and NSCLC) at St. Olavs Hospital 2. Potentially curable disease at the referral time (Stage I-III, based on the first CT) 3. Age ≥ 18 years 4. ECOG Performance 0-2 5. No serious concomitant disorders (for example marked reduced respiratory capacity, active infection, unstable cardiovascular disease, renal dysfunction) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study procedure 6. No contraindication for study specific procedure - bronchoscopy, CT, MRI and PET. 7. No conditions - medical, social, psychological - which could prevent adequate information and follow-up 8. No pregnancy or lactating women 9. Written informed consent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St.Olavs Hospital, Trondheim University Hospital, Dept of Thoracic Medicine

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sveinung Sørhaug, MD PhD

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

NO (1)