[18F]-Fluorodeoxyglucose Positron Emission Tomography in Lung Tumour Assessment, Research into Characteristics

Completed

• Conditions: lung cancer; non-small cell lung carcinoma; 10038666; 10029107

• Registration Number: NL-OMON32809
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

Adult patients (age 18 years and over) with:
-Newly diagnosed or suspected NSCLC stage IB, IIB or limited stage III (T3N1) (at least 30mm in smallest diameter);
-Primary surgical resection (wedge excision, segmentectomy, lobectomy or pneumonectomy).

Exclusion Criteria

- Neoadjuvant treatment prior to surgery;
- No staging CT or FDG-PET available;
- Contra-indication for surgery:
o Based on (biological) age, cardiovascular risk factors, expected remaining lung function, performance status or other co-morbidity as decided by a multidisciplinary team including medical oncologists, thorax surgeons, pulmonologists, radiation oncologists, pathologists, radiologists and nuclear medicine physicians.
- Contra-indication for dynamic FDG-PET:
o Diabetes mellitus;
o Pregnancy;
o Breast-feeding;
o Severe claustrophobia.
o Post-obstruction pneumonia (false-positive FDG-PET)
- Interval between staging CT/FDG-PET, dynamic FDG-PET and surgery more than 28 days;
- Histology proven non-NSCLC or high suspicion for tumour of other origin (e.g. metastasis of colorectal, breast or pharyngeal origin);
- Inability to give informed consent.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Biological and dimensional correlation between FDG-PET, CT and surgical derived<br /><br>specimens. These parameters will be used in prediction models for patient<br /><br>survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Use the most accurate technique found in (dynamic) FDG-PET tumour delineation<br /><br>for analysis of tumour activity, blood fraction, heterogeneity and full kinetic<br /><br>parameters and to correlate these with both histological findings (2A) and<br /><br>patient prognosis (2B) to come to in vivo predictive biological parameters.</p><br>