Primary outcome· 1 day
Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging
| Group | Value |
|---|---|
| DOTATOC Imaging | not posted |
Trial · Interventional
TerminatedPhase 1/2Results postedRegistry dataGA-68 DOTA-TOC of Somatostatin Positive Malignancies
Short name DOTA-TOC
This trial was stopped early.
Reason given at the registry: FDA approved agent for this indication during enrollment
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 1/2
- Enrollment
- 300 participants (actual)
- Sponsor
- University of California, San Francisco · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 23 Jun 2014
- Primary completion
- 7 Aug 2017
- Completion
- 7 Aug 2017
- First posted
- 30 Jun 2014 (estimated)
- Last update posted
- 12 Nov 2019
- Conditions
- Neuroendocrine Tumor · Paraganglioma · Carcinoid Tumors · Neuroblastoma
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20142015201620172018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.
Interventions
- Computed Tomography (CT)Procedure
- Gallium Ga 68-EdotreotideDrug
- Magnetic Resonance Imaging (MRI)Procedure
- Positron Emission Tomography (PET)Procedure
Arms1
Experimental
Ga-68 DOTA-TOC PET/CT
Patients receive Gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo either a PET/CT scan lasting 30-40 minutes or a PET/MRI scan lasting 50 minutes.
Primary outcomes3
Outcomes the sponsor listed as primary.
Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging
Time frame · 1 day
Registry description
The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT
Standardized Uptake Value Maximum (SUVmax)
Time frame · 1 day
Registry description
The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded.
Inter-reader Variability
Time frame · 1 day
Registry description
Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values.
Secondary outcomes(1)
Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging
Time frame · Up to 2 weeks
Registry description
Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both "Change in stage" with a 95% confidence interval determined.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcome· 1 day
Standardized Uptake Value Maximum (SUVmax)
| Group | Value |
|---|---|
| DOTATOC Imaging | not posted |
Primary outcome· 1 day
Inter-reader Variability
| Group | Value |
|---|---|
| DOTATOC Imaging | not posted |
Secondary and other outcome results(1)
Secondary outcome· Up to 2 weeks
Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging
| Group | Value |
|---|---|
| DOTATOC Imaging | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| DOTATOC ImagingAll patients received a single DOTATOC imaging study. | 0 / 300 | 0 / 300 | 0 / 300 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 2 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
* Age \> 1.
* Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) equivalent).
* Not pregnant. A negative serum pregnancy test is required for all female subjects with childbearing potential.
* Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
* Hepatic enzymes 5 times greater than the upper limits of normal, serum creatinine \> 3.0 mg/dL (270 Micromole per liter (uM/L).
* Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET /CT scanner due to BMI
* Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.); although at Mission Bay Hospital pediatric patients may be sedated per clinical protocol.
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
* Recognized concurrent active infection Previous systemic or radiation treatment for another cancer of any type within the last 2 months.
* 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
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