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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32809
Enrollment
54
Registered
2008-12-08
Start date
2009-03-27
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer non-small cell lung carcinoma

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Biological and dimensional correlation between FDG-PET, CT and surgical derived specimens. These parameters will be used in prediction models for patient survival.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)