Neuroendocrine Carcinoma
Conditions
Keywords
neuroendocrine, neuroendocrine carcinoma, neuroendocrine tumor, carcinoid, carcinoid tumor, islet cell tumor, APUDoma, Gallium, PET Scan
Brief summary
Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. The investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.
Detailed description
Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 68GaDOTATATE and undergo a PET/CT imaging study. Scans will be performed with negative oral contrast (e.g. Volumen™ or equivalent), as many NETs involve the GI tract.
Interventions
RADIATION68Ga-DOTATATE PET scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography (PET). Efficacy of the 68Ga-DOTATATE PET scan was assessed and compared to 111In-Pentetreotide scan and to scans with CT and/or MRI. Safety and toxicity were also assessed with pre-injection and post-imaging vital signs, pulse oximetry on room air, 12 lead ECGs, and blood laboratory tests, including tumor markers, liver and renal functions and blood counts, and direct patient questioning. Late delayed tumor markers, liver and renal functions and blood counts were assessed when available.
Sponsors
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Known diagnosis of neuroendocrine tumor * At least 18 years of age * Able to provide informed consent * Karnofsky score greater than 50 * Females of childbearing potential must have a negative pregnancy test at screening/baseline
Exclusion criteria
* Serum creatinine \>3.0 mg/dL (270 μM/L) * Hepatic enzyme levels more than 5 times upper limit of normal. * Known severe allergy or hypersensitivity to IV radiographic contrast. * 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. * Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result. * 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.) * Recognized concurrent active infection * 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 |
|---|---|---|
| Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan | at 1 year | Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability | at 1 year | Determine if any adverse effects are associated with the 68Ga-DOTATATE PET scan and the number of patients that experience them using NCI Common Terminology Criteria for Adverse Events v4.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death. Toxicities present at baseline and continuing without change in grade were excluded for assessment of this outcome measure. |
Countries
United States
Participant flow
Recruitment details
This diagnostic study was conducted at Vanderbilt University/Ingram Cancer Center from March 2011-November 2013, at which time the study met target accrual and closed to accrual.
Pre-assignment details
Ninety-nine patients were consented on this trial. Two consented patients were determined not eligible resulting in 97 patients on study.
Participants by arm
| Arm | Count |
|---|---|
| Imaging/Scans 68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography. | 97 |
| Total | 97 |
Baseline characteristics
| Characteristic | Imaging/Scans |
|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 28.4 |
| Region of Enrollment United States | 97 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 97 |
| serious Total, serious adverse events | 0 / 97 |
Outcome results
Primary
Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan
Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).
Time frame: at 1 year
Population: A major change in management is defined as:planned surgery cancelled, added, or a different type of surgery was planned, or a medication was added or stopped, or a new treatment modality (e.g. radiation) was added. A minor change was adjustment to planned surgery or radiation field, or in current medication dosage.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 68Ga-DOTATATE PET | Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan | Patients experienced a major change | 19 participants |
| 68Ga-DOTATATE PET | Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan | Patients experienced a minor change | 9 participants |
| 68Ga-DOTATATE PET | Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan | Patients experienced no change | 50 participants |
Secondary
Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability
Determine if any adverse effects are associated with the 68Ga-DOTATATE PET scan and the number of patients that experience them using NCI Common Terminology Criteria for Adverse Events v4.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death. Toxicities present at baseline and continuing without change in grade were excluded for assessment of this outcome measure.
Time frame: at 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 68Ga-DOTATATE PET | Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability | 0 participants |