- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2010-03
2014-05
2014-12
97
NCT01396382
Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
INTERVENTIONAL
68Ga-DOTATATE PET Scan in Neuroendocrine Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-07-11 | 2016-01-14 | 2016-02-25 |
2011-07-14 | 2016-02-25 | 2016-03-29 |
2011-07-18 | 2016-03-29 | 2016-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 68Ga-DOTATATE PET Patients will receive a 68Ga-DOTATATE PET scans | RADIATION: 68Ga-DOTATATE PET scan
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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). | at 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | at 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
