NCT01869725 · REGISTRY CONDITION SEARCH

Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2021-09-22

This clinical trial studies gallium Ga 68-edotreotide positron emission tomography (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of patients with neuroendocrine tumors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

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

→

outcome · POSTED

Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan

→

outcome · POSTED

Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Signed informed consent * Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or other somatostatin receptor positive tumor * Off Sandostatin (octreotide acetate)-long acting release (LAR) \> 4 weeks and off immediate release (subcutaneous) for 12 hrs prior to 68Ga-DOTATOC PET-CT * Karnofsky performance status or Lansky Play Scale status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent) * Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (\> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative; a negative serum pregnancy test will be required for all female subjects with child bearing potential; if a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is capable of becoming pregnant * No therapy other than Sandostatin since last Octreoscan + diagnostic CT * Fresh frozen (recommended) or paraffin fixed (required) specimen of primary or metastases available for ribonucleic acid (RNA) and immunohistochemistry (IHC) Exclusion Criteria: * Pregnancy or breast feeding * Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed * Medical condition uncontrolled by treatment making completion of study unlikely * Weight more than 400 pounds (subjects who weigh more than 400 pounds will not be able to fit inside the imaging machines) * Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.) * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
healthy Volunteers: false
minimum Age: 2 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm 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.
intervention Names
Drug: gallium Ga 68-edotreotide
Procedure: positron emission tomography/computed tomography
Radiation: indium In 111 pentetreotide
Procedure: computed tomography
Procedure: contrast-enhanced magnetic resonance imaging
label
Diagnostic (gallium Ga 68-edotreotide PET/CT)
type
EXPERIMENTAL

interventions

arm Group Labels
Diagnostic (gallium Ga 68-edotreotide PET/CT)
description
Given IV
name
gallium Ga 68-edotreotide
other Names
Ga-68 DOTA0-Tyr3-octreotide
Ga-68 DOTATOC
type
DRUG
arm Group Labels
Diagnostic (gallium Ga 68-edotreotide PET/CT)
description
Undergo gallium Ga 68-edotreotide PET/CT scan
name
positron emission tomography/computed tomography
type
PROCEDURE
arm Group Labels
Diagnostic (gallium Ga 68-edotreotide PET/CT)
description
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
name
indium In 111 pentetreotide
other Names
Indium-111 Octreotide DTPA
Indium-111-DTPA-D-Phe-1-octreotide
Indium-In 111 Pentetreotide
Indium-In-111-Pentetreotide
Octreoscan
type
RADIATION
arm Group Labels
Diagnostic (gallium Ga 68-edotreotide PET/CT)
description
Undergo indium In 111 pentetreotide contrast-enhanced CT scan
name
computed tomography
other Names
tomography, computed
type
PROCEDURE
arm Group Labels
Diagnostic (gallium Ga 68-edotreotide PET/CT)
description
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
name
contrast-enhanced magnetic resonance imaging
other Names
Contrast-enhanced MRI
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

DIAGNOSTIC

Enrollment

count: 68
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.
measure
Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
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)
description
Compare sensitivity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors
measure
Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
time Frame
Up to 6 months
description
Compare specificity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors
measure
Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
time Frame
6 months

Full study description

brief Summary: This clinical trial studies gallium Ga 68-edotreotide positron emission tomography (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of patients with neuroendocrine tumors.
detailed Description: PRIMARY OBJECTIVES: I. To compare efficacy of \[68Ga\]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga 68-edotreotide) PET/CT with Octreoscan (indium In 111 pentetreotide) + high-resolution, contrast-enhanced CT for diagnosis and staging in patients with somatostatin receptor expressing tumors. OUTLINE: Patients receive gallium Ga 68-edotreotide intravenously (IV) and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may also undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-6321d3bf4f64688c38fa
requested nct id
NCT01869725
primary nct id
NCT01869725
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Pancreatic+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
01a76e78baf8f56cfe95e0782f09da4c35feadf75bd3a5b5f16b81d0db02e709
payload sha256
29eafaf4a29e8034a92f6fc3596467d2599cd0b5664c4f39ea4c3ff0ee85d617
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-6321d3bf4f64688c38fa
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT01869725
occurrences
context exact
NCT01869725
end
11
exact text
NCT01869725
start
0
offset unit
unicode_code_points
query cond
Childhood Pancreatic Cancer
query disease state id
ds-pancreatic-cancer-pediatric
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-pancreatic-cancer-000.json
source file sha256
01a76e78baf8f56cfe95e0782f09da4c35feadf75bd3a5b5f16b81d0db02e709
source json pointer
/studies/3/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
99a282c46874c694876bf5efaca6ea9b903c00c28c940eaa502516a1350813e2
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Pancreatic+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-9228de9bdd51d88a0eb2
requested nct id
NCT01869725
primary nct id
NCT01869725
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Gastrointestinal+Neuroendocrine+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
d2c292bf8e174e3ccf7707378d78dd3ed4055f4e8bf657746c98d2f6d2bc806b
payload sha256
4348ecc5cf7cbb6d04f1611a3e08cdc85d72e06ed3a53511bf5e9948a0bdd74b
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-9228de9bdd51d88a0eb2
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT01869725
occurrences
context exact
NCT01869725
end
11
exact text
NCT01869725
start
0
offset unit
unicode_code_points
query cond
Childhood Gastrointestinal Neuroendocrine Tumors
query disease state id
ds-gastrointestinal-neuroendocrine-tumors-pediatric
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-gastrointestinal-neuroendocrine-tumors-000.json
source file sha256
d2c292bf8e174e3ccf7707378d78dd3ed4055f4e8bf657746c98d2f6d2bc806b
source json pointer
/studies/1/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
99a282c46874c694876bf5efaca6ea9b903c00c28c940eaa502516a1350813e2
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Gastrointestinal+Neuroendocrine+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice