Neuroendocrine Tumor, Paraganglioma, Carcinoid Tumors, Neuroblastoma
Conditions
Brief summary
This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.
Detailed description
PRIMARY OBJECTIVES: I. To determine if gallium Ga 68-DOTA-TOC (gallium-68 labeled DOTA-TOC) results in the delineation of more lesions than with conventional imaging. SECONDARY OBJECTIVES: I. To determine if the incorporation of gallium (Ga)-68 DOTA-TOC PET/CT into the management decision making process results in a change in stage of the patient. OUTLINE: Patients receive gallium Ga 68-DOTA-TOC intravenously (IV) over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes. After completion of study, patients are followed up for 2 weeks.
Interventions
PROCEDUREPositron Emission Tomography (PET)
Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI
PROCEDUREComputed Tomography (CT)
Undergo Gallium Ga 68-DOTA-TOC PET/CT
Given Intravenously (IV) before imaging
PROCEDUREMagnetic Resonance Imaging (MRI)
Undergo gallium Ga 68-DOTA-TOC PET/MRI
Sponsors
Peterson Family Foundation
University of California, San Francisco
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
* Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report. * Age \> 1. * Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) equivalent). * Not pregnant. A negative serum pregnancy test is required for all female subjects with childbearing potential. * Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
* Hepatic enzymes 5 times greater than the upper limits of normal, serum creatinine \> 3.0 mg/dL (270 Micromole per liter (uM/L). * Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET /CT scanner due to BMI * Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.); although at Mission Bay Hospital pediatric patients may be sedated per clinical protocol. * 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. * Recognized concurrent active infection Previous systemic or radiation treatment for another cancer of any type within the last 2 months. * Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging | 1 day | The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT |
| Standardized Uptake Value Maximum (SUVmax) | 1 day | The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded. |
| Inter-reader Variability | 1 day | Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging | Up to 2 weeks | Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both Change in stage with a 95% confidence interval determined. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ga-68 DOTA-TOC PET/CT Patients receive gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes.
Computed Tomography: Undergo gallium Ga 68-DOTA-TOC PET/CT
Gallium Ga 68-Edotreotide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo gallium Ga 68-DOTA-TOC PET/MRI
Positron Emission Tomography: Undergo gallium Ga 68-DOTA-TOC PET/CT
Positron Emission Tomography: Undergo gallium Ga 68-DOTA-TOC PET/MRI | 300 |
| Total | 300 |
Baseline characteristics
| Characteristic | Ga-68 DOTA-TOC PET/CT |
|---|---|
| Age, Customized 10-19 years | 2 Participants |
| Age, Customized 20-29 years | 6 Participants |
| Age, Customized 30-39 years | 22 Participants |
| Age, Customized 40-49 years | 38 Participants |
| Age, Customized 50-59 years | 71 Participants |
| Age, Customized 60-69 years | 106 Participants |
| Age, Customized 70-79 years | 48 Participants |
| Age, Customized 80-89 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 226 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 69 Participants |
| Race (NIH/OMB) White | 201 Participants |
| Region of Enrollment United States | 300 participants |
| Sex: Female, Male Female | 148 Participants |
| Sex: Female, Male Male | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 300 |
| other Total, other adverse events | 0 / 300 |
| serious Total, serious adverse events | 0 / 300 |
Outcome results
Primary
Inter-reader Variability
Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values.
Time frame: 1 day
Population: Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.
Primary
Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging
The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT
Time frame: 1 day
Population: Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.
Primary
Standardized Uptake Value Maximum (SUVmax)
The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded.
Time frame: 1 day
Population: Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.
Secondary
Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging
Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both Change in stage with a 95% confidence interval determined.
Time frame: Up to 2 weeks
Population: Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.