Trial Outcomes & Findings for TOF-18F-FDG-PET/CT in Patients With Suspected Pancreatic Cancer (NCT NCT03914950)
NCT ID: NCT03914950
Last Updated: 2020-05-29
Results Overview
Quantitative measurement of regional tracer uptake by SUVmax in the TOF-PET/CT and standard PET/CT images over the FDG-accumulating lesions in the pancreas 30 and 90min p.i. The histopathological findings (malignant or benign) were assigned to the corresponding SUVmax values of the pancreatic lesions for the calculation of AUC values in ROC analysis. Then AUC values with and without TOF were compared with the DeLong-test to analyze if there is a significant difference in characterization of pancreatic lesions with TOF.
COMPLETED
NA
174 participants
2 hours
2020-05-29
Participant Flow
Participants were recruited based on physician referral at one university hospital between February 2014 and January 2019. The first participant was enrolled on February 7, 2014, and the last participant was enrolled in January 2019.
Of 174 enrolled participants, 120 participants met ALL inclusion criteria having TOF-18F-FDG PET/CT with diagnostic CT of the abdomen or upper abdomen AND biopsy or FNA or operation of the pancreas and were analyzed. Participants not completing the study were excluded and therefore not analyzed (54 participants).
Participant milestones
| Measure |
PET/CT Results With TOF/Without TOF
Participants received TOF-18F-FDG PET/CT 30 and 90min p.i. and diagnostic CT of the abdomen or upper abdomen (in case of already performed diagnostic CT of the abdomen \< 2 weeks ago) with contrast medium in the case of normal creatinine, GFR, and TSH levels (101 participants). In the case of elevated creatinine or decreased GFR or TSH levels a diagnostic CT without contrast medium was performed (19 participants). After PET/CT examination the participants received a biopsy or FNA (fine-needle aspiration) or operation of the pancreas.
|
|---|---|
|
Overall Study
STARTED
|
174
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
PET/CT Results With TOF/Without TOF
Participants received TOF-18F-FDG PET/CT 30 and 90min p.i. and diagnostic CT of the abdomen or upper abdomen (in case of already performed diagnostic CT of the abdomen \< 2 weeks ago) with contrast medium in the case of normal creatinine, GFR, and TSH levels (101 participants). In the case of elevated creatinine or decreased GFR or TSH levels a diagnostic CT without contrast medium was performed (19 participants). After PET/CT examination the participants received a biopsy or FNA (fine-needle aspiration) or operation of the pancreas.
|
|---|---|
|
Overall Study
Physician Decision
|
54
|
Baseline Characteristics
85 of 120 participants had malignant pancreatic lesions.
Baseline characteristics by cohort
| Measure |
PET/CT Results With TOF/Without TOF
n=120 Participants
Participants received TOF-18F-FDG PET/CT 30 and 90 min p.i. and diagnostic CT of the abdomen or upper abdomen (in case of already performed diagnostic CT of the abdomen \< 2 weeks ago) with contrast medium in case of normal creatinine, GFR, and TSH levels. In the case of elevated creatinine and decreased GFR and TSH levels a diagnostic CT without contrast medium was performed. After PET/CT examination participants received biopsy or FNA or operation of the pancreas.
|
|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 10.4 • n=120 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
120 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=120 Participants
|
|
Region of Enrollment
Austria
|
120 participants
n=120 Participants
|
|
Type of pancreatic mass
Solid
|
86 Participants
n=120 Participants
|
|
Type of pancreatic mass
Solid-cystic
|
11 Participants
n=120 Participants
|
|
Type of pancreatic mass
Cystic
|
23 Participants
n=120 Participants
|
|
History of pancreatitis
|
21 Participants
n=120 Participants
|
|
Dignity of pancreatic lesions
Malignant
|
85 Participants
n=120 Participants
|
|
Dignity of pancreatic lesions
Benign
|
35 Participants
n=120 Participants
|
|
Pathological diagnoses of malignant pancreatic lesions
Adenocarcinoma
|
70 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of malignant pancreatic lesions
Acinuscellcarcinoma
|
1 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of malignant pancreatic lesions
Diffuse large cell-B-cell lymphoma
|
1 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of malignant pancreatic lesions
Follicular lymphoma
|
1 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of malignant pancreatic lesions
Myeloid sarcoma
|
1 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of malignant pancreatic lesions
Neuroendocrine carcinoma
|
1 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of malignant pancreatic lesions
Moderately differentiated neuroendocrine tumor (G2
|
2 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of malignant pancreatic lesions
IPMN adenocarcinoma invasive
|
1 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of malignant pancreatic lesions
IPMN carcinoma non-invasive
|
2 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of malignant pancreatic lesions
Pancreatic intraepithelial neoplasia III(PanINIII)
|
4 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of malignant pancreatic lesions
Mesenchymal neoplasia
|
1 Participants
n=85 Participants • 85 of 120 participants had malignant pancreatic lesions.
|
|
Pathological diagnoses of benign pancreatic lesions
Acute pancreatitis
|
3 Participants
n=35 Participants • 35 of 120 participants had benign pancreatic lesions.
|
|
Pathological diagnoses of benign pancreatic lesions
Chronic pancreatitis
|
11 Participants
n=35 Participants • 35 of 120 participants had benign pancreatic lesions.
|
|
Pathological diagnoses of benign pancreatic lesions
Mucinous cystic neoplasm (MCN) adenoma
|
2 Participants
n=35 Participants • 35 of 120 participants had benign pancreatic lesions.
|
|
Pathological diagnoses of benign pancreatic lesions
IPMN borderline-lesion
|
2 Participants
n=35 Participants • 35 of 120 participants had benign pancreatic lesions.
|
|
Pathological diagnoses of benign pancreatic lesions
Serous cyst adenoma
|
3 Participants
n=35 Participants • 35 of 120 participants had benign pancreatic lesions.
|
|
Pathological diagnoses of benign pancreatic lesions
Benign cyst
|
1 Participants
n=35 Participants • 35 of 120 participants had benign pancreatic lesions.
|
|
Pathological diagnoses of benign pancreatic lesions
Highly differentiated neuroendocrine tumor
|
1 Participants
n=35 Participants • 35 of 120 participants had benign pancreatic lesions.
|
|
Pathological diagnoses of benign pancreatic lesions
No indication of malignancy
|
12 Participants
n=35 Participants • 35 of 120 participants had benign pancreatic lesions.
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: 120 participants meeting ALL inclusion criteria, i.e. completed TOF-18F-FDG PET/CT AND biopsy or FNA or operation were analyzed. 54 participants had TOF-18F-FDG PET/CT but no biopsy or FNA or operation or the tumor was not in the pancreas and were therefore excluded from the study.
Quantitative measurement of regional tracer uptake by SUVmax in the TOF-PET/CT and standard PET/CT images over the FDG-accumulating lesions in the pancreas 30 and 90min p.i. The histopathological findings (malignant or benign) were assigned to the corresponding SUVmax values of the pancreatic lesions for the calculation of AUC values in ROC analysis. Then AUC values with and without TOF were compared with the DeLong-test to analyze if there is a significant difference in characterization of pancreatic lesions with TOF.
Outcome measures
| Measure |
SUVmax TOF 30min p.i.
n=120 Participants
SUVmax values of the pancreatic lesions with TOF 30min p.i.
|
SUVmax Without TOF 30min p.i.
n=120 Participants
SUVmax values of the pancreatic lesions without TOF 30min p.i.
|
SUVmax TOF 90min p.i.
n=120 Participants
SUVmax values of the pancreatic lesions with TOF 90min p.i.
|
SUVmax Without TOF 90min p.i.
n=120 Participants
SUVmax values of the pancreatic lesions without TOF 90min p.i.
|
|---|---|---|---|---|
|
SUVmax (Maximal Standard Uptake Value) Measurement 30 and 90 Min p.i. (Post Injection)
|
0.77 SUVmax
|
0.78 SUVmax
|
0.81 SUVmax
|
0.8 SUVmax
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: 120 participants meeting ALL inclusion criteria, i.e. completed TOF-18F-FDG PET/CT AND biopsy or FNA or operation were analyzed. 54 participants had TOF-18F-FDG PET/CT but no biopsy or FNA or operation or the tumor was not in the pancreas and were therefore excluded from the study.
The number of participants with increased tracer uptake over the pancreatic lesion, i.e. the number of pancreatic lesions with increased tracer uptake with and without TOF. One pancreatic lesion per patient was measured.
Outcome measures
| Measure |
SUVmax TOF 30min p.i.
n=120 Participants
SUVmax values of the pancreatic lesions with TOF 30min p.i.
|
SUVmax Without TOF 30min p.i.
n=120 Participants
SUVmax values of the pancreatic lesions without TOF 30min p.i.
|
SUVmax TOF 90min p.i.
SUVmax values of the pancreatic lesions with TOF 90min p.i.
|
SUVmax Without TOF 90min p.i.
SUVmax values of the pancreatic lesions without TOF 90min p.i.
|
|---|---|---|---|---|
|
Participants With Increased Tracer Uptake Over the Pancreatic Lesion With and Without TOF
|
116 Participants
|
101 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: 120 participants meeting ALL inclusion criteria, i.e. completed TOF-18F-FDG PET/CT AND biopsy or FNA or operation were analyzed. 54 participants had TOF-18F-FDG PET/CT but no biopsy or FNA or operation or the tumor was not in the pancreas and were therefore excluded from the study.
Lesion or tumor size in cm in the pancreas measured in the diagnostic CT of the abdomen or upper abdomen.
Outcome measures
| Measure |
SUVmax TOF 30min p.i.
n=120 Participants
SUVmax values of the pancreatic lesions with TOF 30min p.i.
|
SUVmax Without TOF 30min p.i.
SUVmax values of the pancreatic lesions without TOF 30min p.i.
|
SUVmax TOF 90min p.i.
SUVmax values of the pancreatic lesions with TOF 90min p.i.
|
SUVmax Without TOF 90min p.i.
SUVmax values of the pancreatic lesions without TOF 90min p.i.
|
|---|---|---|---|---|
|
Lesion Size
|
3.0 cm
Standard Deviation 1.67
|
—
|
—
|
—
|
Adverse Events
PET/CT Results With TOF/ Without TOF
Serious adverse events
| Measure |
PET/CT Results With TOF/ Without TOF
n=101 participants at risk
101 participants received diagnostic CT of the abdomen/upper abdomen with contrast medium within the PET/CT examination and 19 participants had diagnostic CT of the abdomen or upper abdomen without contrast medium due to elevated creatine or decreased GFR (glomerular filtration rate) or TSH (thyroid-stimulating hormone) levels.
|
|---|---|
|
Cardiac disorders
Hypotensive shock
|
0.00%
0/101 • 1 day
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/101 • 1 day
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/101 • 1 day
|
|
Nervous system disorders
Convulsion
|
0.00%
0/101 • 1 day
|
Other adverse events
| Measure |
PET/CT Results With TOF/ Without TOF
n=101 participants at risk
101 participants received diagnostic CT of the abdomen/upper abdomen with contrast medium within the PET/CT examination and 19 participants had diagnostic CT of the abdomen or upper abdomen without contrast medium due to elevated creatine or decreased GFR (glomerular filtration rate) or TSH (thyroid-stimulating hormone) levels.
|
|---|---|
|
Gastrointestinal disorders
Severe vomiting
|
0.00%
0/101 • 1 day
|
|
Gastrointestinal disorders
Nausea, mild vomiting
|
0.00%
0/101 • 1 day
|
|
Skin and subcutaneous tissue disorders
Marked urticaria
|
0.00%
0/101 • 1 day
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/101 • 1 day
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/101 • 1 day
|
|
Skin and subcutaneous tissue disorders
Facial edema
|
0.00%
0/101 • 1 day
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/101 • 1 day
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/101 • 1 day
|
|
Nervous system disorders
Vasovagal attack
|
0.00%
0/101 • 1 day
|
Additional Information
Dr. Susanne Stanzel
Medical University of Graz, Department of Radiology, Division of Nuclear Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place