Adult Medulloblastoma, Childhood Medulloblastoma, Neuroblastoma, Neuroendocrine Tumor, Somatostatinoma
Conditions
Keywords
Neuroendocrine Tumor, Ga-DOTATOC PET, Imaging
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.
Interventions
Given IV
Undergo gallium Ga 68-edotreotide PET/CT scan
RADIATIONindium In 111 pentetreotide
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
PROCEDUREcomputed tomography
Undergo indium In 111 pentetreotide contrast-enhanced CT scan
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
Sponsors
National Cancer Institute (NCI)
Sue O'Dorisio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | 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) | 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 | Up to 6 months | 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 | 6 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | ineligible after registration | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Diagnostic (Gallium Ga 68-edotreotide PET/CT) |
|---|---|
| Age, Categorical <=18 years | 5 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 55 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 38 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 68 eligible participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 68 |
| other Total, other adverse events | 11 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
Primary
Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
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
Time frame: Up to 6 months
Population: Patients with neuroendocrine tumor or other somatostatin receptor positive tumor
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan | Sensitivity of Ga-68-DOTATOC | 96.55 percentage of sensitivity |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan | Sensitivity of OctreoScan | 79.31 percentage of sensitivity |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan | Sensitivity of Conventional Imaging (CI) | 82.24 percentage of sensitivity |
Primary
Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
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
Time frame: 6 months
Population: Patients with neuroendocrine tumor or other somatostatin receptor positive tumor
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan | Specificity of 68Ga-DOTATOC | 100 percentage of specificity |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan | Specificity of Octreoscan | 100 percentage of specificity |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan | Specificity of Conventional Imaging (CI) | 47.82 percentage of specificity |
Primary
Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.
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)
Population: Patients with neuroendocrine tumor or other somatostatin receptor positive tumor
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology | Total positive | 28 Participants |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology | False position | 0 Participants |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology | False negative | 1 Participants |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology | Total negative | 5 Participants |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | Sensitivity and Specificity for OctreoScan as Compared to Pathology | Total positive | 23 Participants |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | Sensitivity and Specificity for OctreoScan as Compared to Pathology | False position | 0 Participants |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | Sensitivity and Specificity for OctreoScan as Compared to Pathology | False negative | 6 Participants |
| Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | Sensitivity and Specificity for OctreoScan as Compared to Pathology | Total negative | 5 Participants |