NCT01869725 · OUTCOME

Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology

Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT · Source last updated 2021-09-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)

What was measured

Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.

Analysis population: Patients with neuroendocrine tumor or other somatostatin receptor positive tumor

Groups in this outcome

Diagnostic (Gallium Ga 68-edotreotide PET/CT)

Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	34

Reported measurements

Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology

Total positive

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	28	Not reported	Not reported	Not reported	Not reported

False position

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	0	Not reported	Not reported	Not reported	Not reported

False negative

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	1	Not reported	Not reported	Not reported	Not reported

Total negative

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	5	Not reported	Not reported	Not reported	Not reported

Sensitivity and Specificity for OctreoScan as Compared to Pathology

Total positive

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	23	Not reported	Not reported	Not reported	Not reported

False position

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	0	Not reported	Not reported	Not reported	Not reported

False negative

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	6	Not reported	Not reported	Not reported	Not reported

Total negative

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
28
title
Total positive
measurements
group Id
OG000
value
0
title
False position
measurements
group Id
OG000
value
1
title
False negative
measurements
group Id
OG000
value
5
title
Total negative
title
Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology
categories
measurements
group Id
OG000
value
23
title
Total positive
measurements
group Id
OG000
value
0
title
False position
measurements
group Id
OG000
value
6
title
False negative
measurements
group Id
OG000
value
5
title
Total negative
title
Sensitivity and Specificity for OctreoScan as Compared to Pathology

denoms

counts
group Id
OG000
value
34
units
Participants

description

Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.

groups

description
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
id
OG000
title
Diagnostic (Gallium Ga 68-edotreotide PET/CT)

param Type

COUNT_OF_PARTICIPANTS

population Description

Patients with neuroendocrine tumor or other somatostatin receptor positive tumor

reporting Status

POSTED

time Frame

Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)

title

Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice