Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03623984 |
Other study ID # |
IRB-300001980 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
June 7, 2019 |
Est. completion date |
June 7, 2023 |
Study information
Verified date |
September 2023 |
Source |
University of Alabama at Birmingham |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to see if the use of 68Gallium- positron emission tomography and
computer tomography (PET/CT) scans along with NETSPOT® (Advanced Accelerator Applications
USA, Inc.) can better define the localization of Neuroendocrine tumors enhancing the surgical
removal of Neuroendocrine tumors (NETs).
Description:
A challenge during cancer surgery is determining all sites of malignant disease. Accurate
tumor localization is of utmost importance as complete resection increases the chance of cure
and improves patient outcomes even when cure is not possible. However, finding the primary
tumor can be very challenging and, in some cases, impossible. With the recent FDA approval of
a PET tracer (Ga-68 DOTATATE) that binds to somatostatin receptors for imaging neuroendocrine
tumors (NETs), the investigator's institution has the opportunity to dramatically improve the
surgical care for these patients. Therefore, the aim for this study is to develop a molecular
image-guided surgery program starting with GI NETs. GI NETs are malignant neoplasms that are
increasing in prevalence. NETs cause a variety of debilitating symptoms, and, as a result,
contribute substantially to cancer-related morbidity. Since the primary treatment for NET is
surgical resection, NETs are an ideal model to launch a comprehensive image-guided surgery
program. Many NETs are metastatic at presentation or will develop metastases during their
course, and it is difficult to identify all disease visually and through manual palpation.
Failure to surgically resect all disease leads to symptoms, metastatic disease, and multiple
surgical interventions. Many institutions have recently begun using Ga-68 DOTATATE for PET/CT
imaging of NETs, and this same tracer can be used for intra-operative localization of primary
NETs as well as metastases. The primary impediment to using Ga-68 DOTATATE for this purpose
is the need to develop and validate a high-energy gamma (HEG) probe for detecting NETs during
surgery. This study will explore the new PET tracer technology and begin a molecular
image-guided surgery program for NETs. This initial paradigm will be used to develop a
molecular image guided approach to other cancers. It is expected that this type of program
could usher a new era of cancer management at the investigator's institution at its forefront
and improve outcomes for study participants.