To find correlations between tumour dimensions obtained by thresholds of uptake (SUV), metabolism (MRglu) or modelled thresholds (RTL) as measured during dynamic acquisition and anatomic (CT) and pathological data. Secondary objectives are the…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Biological and dimensional correlation between FDG-PET, CT and surgical derived
specimens. These parameters will be used in prediction models for patient
survival.
Secondary outcome
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.
Background summary
Essential for tumour staging, radiotherapy planning and therapy response
monitoring are accurate measurements of tumour volume. For radiotherapy
planning heterogeneity in glucose metabolic rate, as potential marker for
hypoxia or radioinsensitivity, may be important for focal dosage modifications
(dose painting). Different techniques can be used to delineate tumour on
[18F]-fluorodeoxyglucose positron emission tomography (FDG-PET) images.
Determination of region of interest (ROI) does not only have influence on
determination of tumour dimensions but also on (mean) activity measurement.
Different new methods of ROI determination on both static (single timeframe)
FDG-PET and dynamic (multi-timeframe) FDG-PET have been developed, which are
supposed to be more exact for they are less sensitive to partial volume effects
(PVE). Accurate concordance between FDG-PET delineated tumour and pathologic
tumour might not only improve activity measurements, but also its value in
determination of tumour size. New techniques of volumetric measurement on
static (relative threshold level, RTL) and dynamic (parametric maps of glucose
metabolic rate, MRglu) might correlate better with pathology than other
measures of tumour activity measures. We use suspected non-small cell lung
carcinoma (NSCLC) patients who opt for primary surgical resection as model to
compare FDG-PET data with CT and pathologic specimens.
Study objective
To find correlations between tumour dimensions obtained by thresholds of uptake
(SUV), metabolism (MRglu) or modelled thresholds (RTL) as measured during
dynamic acquisition and anatomic (CT) and pathological data. Secondary
objectives are the collection of whole-tumour full kinetic parameter extraction
and tumour heterogeneity and compare these with pathology (vascular fraction).
Finally each of these parameters will be used to evaluated its predictive
ability for survival of patients.
Study design
Observational study using 1 group. Pathologist and nuclear medicine researcher
are blinded for each others results.
Study burden and risks
All patients undergo one extra FDG-PET. This scan will take approximately 1
hour and 15 minutes (including preparation). One intravenous cannula is placed
in the antecubital vein. One blood sample is drawn from that cannula.
Approximately 3.4MBq.kg-1 FDG is injected. Combination of FDG and low-dose CT
exposes the patient to a dose equivalent of 5.9-13.2mSv (depending on
bodyweight, 30 to 150kg respectively). Individual benefit is limited to
possible extra clinical relevant data as to NSCLC staging, which will be
corresponded to the treating physician.
Geert Grooteplein-Zuid 8
6525 GA Nijmegen
NL
Geert Grooteplein-Zuid 8
6525 GA Nijmegen
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24886.091.08 |