Trial Outcomes & Findings for 68Ga-DOTATATE PET Scan in Neuroendocrine Cancer (NCT NCT01396382)

NCT ID: NCT01396382

Last Updated: 2016-03-29

Results Overview

Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 97 participants
• Primary outcome timeframe: at 1 year
• Results posted on: 2016-03-29

Participant Flow

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.

Ninety-nine patients were consented on this trial. Two consented patients were determined not eligible resulting in 97 patients on study.

Participant milestones

Measure	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.
Overall Study STARTED	97
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

Baseline characteristics by cohort

Measure	Imaging/Scans n=97 Participants 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.
Age, Continuous	53.7 years STANDARD_DEVIATION 28.4 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment United States	97 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).

Outcome measures

Measure	68Ga-DOTATATE PET n=78 Participants 68Ga-DOTATATE PET scan will be administered to patients in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan Patients experienced a major change	19 participants
Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan Patients experienced a minor change	9 participants
Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan Patients experienced no change	50 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	68Ga-DOTATATE PET n=78 Participants 68Ga-DOTATATE PET scan will be administered to patients in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability	0 participants

Adverse Events

68Ga-DOTATATE PET Scan

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	68Ga-DOTATATE PET Scan n=97 participants at risk 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.
Metabolism and nutrition disorders hyperglycemia	17.7% 11/62 • Number of events 11 • 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.
Vascular disorders hypertension	12.4% 12/97 • Number of events 12 • 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.
Respiratory, thoracic and mediastinal disorders respiratory rate	6.2% 6/97 • Number of events 6 • 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.
Investigations white blood count	6.7% 5/75 • Number of events 5 • 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.
Investigations Serum bilirubin mg/dl	5.7% 4/70 • Number of events 4 • 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.
Investigations Serum alanine transaminase U/L	10.0% 7/70 • Number of events 7 • 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.
Investigations Serum chloride mEg/L	6.9% 5/72 • Number of events 5 • 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.
Investigations serum bicarbonate mEq/L	11.9% 8/67 • Number of events 8 • 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.
Metabolism and nutrition disorders Serum potassium	8.3% 6/72 • Number of events 6 • 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.

Additional Information

Dr. Ronald Walker

Vanderbilt-Ingram Cancer Center

Phone: 615-343-8516

Email: ronald.walker@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place