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| ID | Type | Description | Link |
|---|---|---|---|
| 110588 | Other Identifier | Vanderbilt University Medical Center, Radiology Dept |
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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. Volumenâ„¢ or equivalent), as many NETs involve the GI tract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-DOTATATE PET | Experimental | Patients will receive a 68Ga-DOTATATE PET scans |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTATATE PET scan | Radiation | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald C. Walker, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23516312 | Result | Walker RC, Smith GT, Liu E, Moore B, Clanton J, Stabin M. Measured human dosimetry of 68Ga-DOTATATE. J Nucl Med. 2013 Jun;54(6):855-60. doi: 10.2967/jnumed.112.114165. Epub 2013 Mar 20. | |
| 26769865 | Result | Deppen SA, Liu E, Blume JD, Clanton J, Shi C, Jones-Jackson LB, Lakhani V, Baum RP, Berlin J, Smith GT, Graham M, Sandler MP, Delbeke D, Walker RC. Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors. J Nucl Med. 2016 May;57(5):708-14. doi: 10.2967/jnumed.115.163865. Epub 2016 Jan 14. |
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Data are primarily imaging data and toxicity data submitted for peer-review publication and US FDA review, but not shared with a public data archive.
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Ninety-nine patients were consented on this trial. Two consented patients were determined not eligible resulting in 97 patients on study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 68Ga-DOTATATE PET Scan | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
patients with known or suspected pulmonary or gastroenteropancreatic (GEP) neuroendocrine tumors (NETS)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | at 1 year |
|
Adverse event data were collected for 10 days minimum and up to 3 years, and/or until lost to follow-up. Some patients living outside the local region had limited long term follow-up.
Toxicity data were compiled and individual patient test results pre-and-post-scans were compared. Non-systematic assessment was used for patients with limited long term follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 68Ga-DOTATATE PET Scan | Patients will receive 68Ga-DOTATATE PET scans. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyperglycemia | Metabolism and nutrition disorders | NCI criteria v4 | Non-systematic Assessment |
Long term follow-up of lab values was limited in some patients who lived outside the local region.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronald Walker | Vanderbilt-Ingram Cancer Center | 615-343-8516 | ronald.walker@vanderbilt.edu |
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| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D002276 | Carcinoid Tumor |
| D007516 | Adenoma, Islet Cell |
| D001079 | Apudoma |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| at 1 year |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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). | 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. | Posted | Number | participants | at 1 year |
|
|
|
| 0 |
| 97 |
| 51 |
| 97 |
| hypertension | Vascular disorders | NCI criteria v4 | Non-systematic Assessment |
|
| respiratory rate | Respiratory, thoracic and mediastinal disorders | NCI criteria v4 | Non-systematic Assessment |
|
| white blood count | Investigations | NCI criteria v4 | Non-systematic Assessment |
|
| Serum bilirubin mg/dl | Investigations | NCI criteria v4 | Non-systematic Assessment |
|
| Serum alanine transaminase U/L | Investigations | NCI criteria v4 | Non-systematic Assessment |
|
| Serum chloride mEg/L | Investigations | NCI criteria v4 | Non-systematic Assessment |
|
| serum bicarbonate mEq/L | Investigations | NCI criteria v4 | Non-systematic Assessment |
|
| Serum potassium | Metabolism and nutrition disorders | NCI criteria v4 | Non-systematic Assessment |
|
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| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D000236 | Adenoma |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| Title | Measurements |
|---|---|
|