Clinical trial NCT03623984: Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers
Official title: Molecular-Guided Surgery for Pancreatic and Gastrointestinal Neuroendocrine Cancers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Neuroendocrine Carcinoma of Pancreas
Carcinoid
Keywords: Gallium-DOTATATE (68)
Neuroendocrine Tumors
Pancreatic neuroendocrine Tumors
Molecular
Surgery
Carcinoid
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. At least 19 years of age and older
2. Male or female patient with a suspected diagnosis of a gastrointestinal-pancreatic neuroendocrine tumor (localized or metastatic) to undergo surgery for resection
3. Localization of the tumor with a pre-operative 68Gallium-DOTATATE scan
4. In the Investigator's judgement, participant is mentally competent to provide informed consent to participate in the study.
5. ECOG performance status of 0-1
6. Negative urine pregnancy test at screening, if applicable.

Exclusion Criteria:

1. Participants who are pregnant, lactating, or intending to become pregnant during the study
2. Female participants of child-bearing age who refuse a urine pregnancy test
3. Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
4. Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.
5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
6. Patients whose tumors do not localize on a 68Gallium-DOTATATE scan

Primary outcomes:
measure: Comparison of intraoperative findings to preoperative PET scan findings
timeFrame: From initial PET scan (2-3 weeks) until completion of the surgery
Secondary outcomes:
measure: Determine threshold levels of gallium dotatate uptake in order to determine tumor involvement
timeFrame: From baseline through 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Kirklin Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Sushanth Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: