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Trial record 29 of 47 for:    DOTATATE | Neuroendocrine Tumors

68Ga-DOTATATE PET Scan in Neuroendocrine Cancer (68Ga)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01396382
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ronald C. Walker MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Neuroendocrine Carcinoma
Intervention Radiation: 68Ga-DOTATATE PET scan
Enrollment 97
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.
Arm/Group Title 68Ga-DOTATATE PET Scan
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 97
Completed 97
Not Completed 0
Arm/Group Title Imaging/Scans
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 97
Hide Baseline Analysis Population Description
patients with known or suspected pulmonary or gastroenteropancreatic (GEP) neuroendocrine tumors (NETS)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants
53.7  (28.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants
Female
56
  57.7%
Male
41
  42.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 97 participants
97
1.Primary Outcome
Title Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 68Ga-DOTATATE PET
Hide Arm/Group Description:
68Ga-DOTATATE will be administered to patient in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: participants
Patients experienced a major change 19
Patients experienced a minor change 9
Patients experienced no change 50
2.Secondary Outcome
Title Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 68Ga-DOTATATE PET
Hide Arm/Group Description:
68Ga-DOTATATE PET scan will be administered to patients in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: participants
0
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title 68Ga-DOTATATE PET Scan
Hide Arm/Group Description 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.
All-Cause Mortality
68Ga-DOTATATE PET Scan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
68Ga-DOTATATE PET Scan
Affected / at Risk (%) # Events
Total   0/97 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
68Ga-DOTATATE PET Scan
Affected / at Risk (%) # Events
Total   51/97 (52.58%)    
Investigations   
white blood count * 1  5/75 (6.67%)  5
Serum bilirubin mg/dl * 1  4/70 (5.71%)  4
Serum alanine transaminase U/L * 1  7/70 (10.00%)  7
Serum chloride mEg/L * 1  5/72 (6.94%)  5
serum bicarbonate mEq/L * 1  8/67 (11.94%)  8
Metabolism and nutrition disorders   
hyperglycemia * 1  11/62 (17.74%)  11
Serum potassium * 1  6/72 (8.33%)  6
Respiratory, thoracic and mediastinal disorders   
respiratory rate * 1  6/97 (6.19%)  6
Vascular disorders   
hypertension * 1  12/97 (12.37%)  12
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI criteria v4
Long term follow-up of lab values was limited in some patients who lived outside the local region.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ronald Walker
Organization: Vanderbilt-Ingram Cancer Center
Phone: 615-343-8516
Responsible Party: Ronald C. Walker MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01396382     History of Changes
Other Study ID Numbers: VICC GI 1136
110588 ( Other Identifier: Vanderbilt University Medical Center, Radiology Dept )
First Submitted: July 11, 2011
First Posted: July 18, 2011
Results First Submitted: January 14, 2016
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016