Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT01869725Other id201212736Other idNCI-2013-00936Other idP30CA086862Other idR01CA167632

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 68 participants (actual)
Sponsor: Sue O'Dorisio · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 1 Apr 2013
Primary completion: 26 Dec 2018
Completion: 26 Dec 2018
First posted: 5 Jun 2013 (estimated)
Last update posted: 22 Sept 2021
Conditions: Adult Medulloblastoma · Childhood Medulloblastoma · Neuroblastoma · Neuroendocrine Tumor · Somatostatinoma

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2013201420152016201720182019

Ph 2
Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT
NCT01869725
1 Apr 2013 to 26 Dec 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

gallium Ga 68-edotreotideDrug
positron emission tomography/computed tomographyProcedure
indium In 111 pentetreotideRadiation
computed tomographyProcedure
contrast-enhanced magnetic resonance imagingProcedure

Arms1

Experimental
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.

Primary outcomes3

Outcomes the sponsor listed as primary.

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)
Registry description
Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.
Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
Time frame · Up to 6 months
Registry 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
Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
Time frame · 6 months
Registry 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 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)

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

Group	Value (Participants)
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	28

Primary outcomeNumber· Up to 6 months

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

Group	Value (percentage of sensitivity)
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	96.55

Primary outcomeNumber· 6 months

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

Group	Value (percentage of specificity)
Diagnostic (Gallium Ga 68-edotreotide PET/CT)	100

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
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	1 / 68	0 / 68	11 / 68

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 2 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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