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Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03623984
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : October 10, 2019
Information provided by (Responsible Party):
Sushanth Reddy, University of Alabama at Birmingham

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).

Condition or disease Intervention/treatment Phase
Neuroendocrine Carcinoma of Pancreas Carcinoid Drug: Gallium Dotatate Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Molecular-Guided Surgery for Pancreatic and Gastrointestinal Neuroendocrine Cancers
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : June 7, 2020
Estimated Study Completion Date : June 7, 2021

Arm Intervention/treatment
Experimental: Gallium Dotatate
All patients in the study will be undergoing both a 68Gallium-DOTATATE scan for tumor localization and planned surgical resection. Both of these maneuvers are clinically indicated and the standard of care in the care of these patients. Following induction of general endotracheal anesthesia (as required for the surgery portion of treatment), the patients will receive an additional injection of 68Gallium-DOTATATE in the operating room itself. A probe that can detect 68Gallium will be used to identify tumors in the OR within the patient's abdominal cavity for targeted resection.
Drug: Gallium Dotatate
Radioguided Surgery for Pancreatic- Neuroendocrine Cancers
Other Name: Gallium-DOTATATE (68)

Primary Outcome Measures :
  1. Comparison of intraoperative findings to preoperative PET scan findings [ Time Frame: From initial PET scan (2-3 weeks) until completion of the surgery ]
    PET probes will be used to quantify the level of gallium dotatate in the tumor tissue and be compared to the gallium dotatate uptake of the preoperative PET scan.

Secondary Outcome Measures :
  1. Determine threshold levels of gallium dotatate uptake in order to determine tumor involvement [ Time Frame: From baseline through 12 months ]
    Using a high energy PET probe the level of gallium uptake will be compared to histopathology analysis of removed specimen

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03623984

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Contact: Sushanth Reddy, MD 205-934-3065

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United States, Alabama
UAB Kirklin Clinic Recruiting
Birmingham, Alabama, United States, 35233
Contact: Sushanth Reddy, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
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Principal Investigator: Sushanth Reddy, MD University of Alabama at Birmingham

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Responsible Party: Sushanth Reddy, Principal Investigator, University of Alabama at Birmingham Identifier: NCT03623984    
Other Study ID Numbers: IRB-300001980
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sushanth Reddy, University of Alabama at Birmingham:
Gallium-DOTATATE (68)
Neuroendocrine Tumors
Pancreatic neuroendocrine Tumors
Additional relevant MeSH terms:
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Carcinoid Tumor
Carcinoma, Neuroendocrine
Pancreatic Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases