Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors

Related Clinical Trial
Retrospective Case Series of Trans-scleral Cryotherapy for Retinal Hemangioblastoma 68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy Study of Brain and Spinal Cord Tumor Growth and Cyst Development in Patients With Von Hippel Lindau Disease Assessment of Residual VHL Function in Tumors – Can it Predict the Patients’ Individual Course of Disease? Phase II Study of Vandetanib in Individuals With Kidney Cancer A Phase 2 Study of PT2977 for the Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma Drivers of Hypoxia-induced Angiogenesis in Tumor Development Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors MyVHL: Patient Natural History Study Metabolic Mapping to Measure Retinal Metabolism Use of Tracking Devices to Locate Abnormalities During Invasive Procedures National Eye Institute Biorepository for Retinal Diseases Evaluation of Sunitinib Malate in Patients With Von Hippel-Lindau Syndrome (VHL) Who Have VHL Lesions to Follow Pazopanib in Von Hippel-Lindau (VHL) Syndrome 17AAG to Treat Kidney Tumors in Von Hippel-Lindau Disease Effect of Vorinostat on Nervous System Hemangioblastomas in Von Hippel-Lindau Disease (Missense Mutation Only) A Phase I/II Trial for Intravitreous Treatment of Severe Ocular Von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome Screening for Endolymphatic Sac Tumours (ELSTs) in Von Hippel-Lindau (vHL) Patients Bevacizumab (Avastin) in Unresectable/Recurrent Hemangioblastoma From Von-Hippel-Lindau Disease EYE001 to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome Von Hippel-Lindau Disease Genetic Epidemiology Study Treatment of Von Hippel-Lindau (VHL)-Related Hemangioblastoma With PTK787/ZK 222584 TKI 258 in Von Hippel-Lindau Syndrome (VHL) Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau Genetic Study to Identify Gene Mutations in Participants Previously Enrolled in Clinical Trial NCI-99-C-0053 Who Have Von Hippel-Lindau Syndrome or Are at Risk for Von Hippel-Lindau Syndrome PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease Natural History and Management of Pancreatic Lesions in Von Hippel-Lindau Disease Sunitinib Malate to Treat Advanced Eye Disease in Patients With Von Hippel-Lindau Syndrome

Brief Title

Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors

Official Title

Evaluation of (68)Gallium- DOTATATE PET/CT for Detecting Primary and Metastatic Neuroendocrine Tumors

Brief Summary

      Background:

      - Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The
      only treatment for NETs is surgery, but most are found when they are too advanced for
      surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can
      be successful. They want to test if the study drug can be used along with imaging devices to
      detect NETs.

      Objectives:

      - To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown
      primary and metastatic NETs in the gastrointestinal system and pancreas.

      Eligibility:

      - Adults over 10 years old with a suspected NET or family history of NET.

      Design:

        -  Participants will be screened with a medical history and physical exam, and have a blood
           test.

        -  Participants will undergo three scans. For all of these, a substance is injected into
           their body, they lie on a table, and a machine takes images.

        -  A standard computed tomography (CT) scan of the chest, abdomen, and pelvis.

        -  An octreotide scintigraphy Single photon emission computed tomography (SPECT)/CT.

        -  A 68Gallium-DOTATATE positron emission tomography (PET)/CT. The study drug is injected
           into a vein, usually in the arm. Low-dose X-rays go through the body. For about 40
           minutes a large, donut-shaped device takes images of the body. The entire session takes
           90 to 120 minutes.

        -  Researchers will compare images from the three scans.

        -  Participants will have 1 follow-up visit each year for 5 years. At this visit, they will
           have a medical exam, blood taken, and a CT scan.
    

Detailed Description

      Background:

        -  Neuroendocrine tumors (NETs) are rare malignancies occurring in the gastrointestinal
           tract, islets of the pancreas, lung, adrenal medulla and thyroid C-cells.

        -  Their incidence has increased over the last decade, with an incidence of 6 per 100,000
           persons a year and they represent 0.46% of all malignancies.

        -  Most NETs are sporadic, but they can be part of familial cancer syndromes such as
           multiple endocrine neoplasia type 1 (MEN1), MEN2, and neurofibromatosis type 1 (NF1) or
           Von Hippel-Lindau (VHL) syndrome.

        -  Surgical resection remains the only curative treatment option for patients with NETs but
           80% of patients are diagnosed with advanced (metastatic, locally inoperable, or
           recurrent) disease.

        -  The main prognostic factor in patients with NET is the extent of disease.

        -  The best imaging technique for detecting unknown primary and metastatic NETs has yet to
           be determined.

        -  NET cells express somatostatin receptors that can be targeted with radiolabeled
           68Gallium-DOTATATE (Octreotate) for imaging purposes.

        -  The primary goal of this protocol is to determine the accuracy of a new somatostatin
           receptor targeted imaging technique, using 68Gallium-DOTATATE PET/CT to detect unknown
           primary and metastatic NETs.

      Objectives:

      -To determine the accuracy of 68Gallium-DOTATATE PET/CT scans in detecting unknown primary
      and metastatic gastrointestinal and pancreatic neuroendocrine tumors.

      Eligibility:

        -  Patients with:

             -  suspicion of NET on axial imaging (CT/magnetic resonance imaging
                (MRI)/fluorodeoxyglucose-positron emission tomography (FDG PET) and/or

             -  biochemical evidence of NET (serum/urinary) based on elevated levels of
                chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive
                intestinal polypeptide, serotonin (urinary 5-HIAA), gastrin, somatostatin,
                catecholamines, metanephrines, calcitonin, fasting insulin, C-peptide (proinsulin),
                glucagon and/or

             -  familial predisposition to NET in patients with multiple endocrine neoplasia type 1
                (MEN1) and VHL.

        -  Age greater than or equal to 18 years of age.

        -  Patients must be willing to return to National Institutes of Health (NIH) for follow-up.

      Design:

        -  Prospective study.

        -  A 68Ga-DOTATATE PET/CT scan will be done in patients with suspicious lesions, unknown
           primary tumor or metastatic gastrointestinal or pancreatic neuroendocrine disease found
           on anatomic imaging (CT/MRI) or in patients having biochemically active disease.

        -  Both functional and non-functional solid tumors will be included in this study.
           Furthermore, asymptomatic and symptomatic, sporadic and familial cases of NETs (such as
           Von Hippel-Lindau (VHL), MEN1) will be included.

        -  Demographic, clinical and pathologic data will be collected from the medical record and
           patient interview for each patient. Data will be stored in a computerized database.

        -  After their initial on-study evaluation, patients will be staged according to findings
           on imaging studies with respect to primary tumor site, size and metastases. Surgical
           resection of NET and/or medical managements will be recommended based on standard
           practice guidelines. In patients who undergo surgical treatment, the samples will be
           immediately stored until molecular analysis.

        -  Follow up will be done yearly for a total duration of 5 years. This includes a yearly
           imaging study and a biochemical and clinical evaluation, to assess tumor growth and
           disease progression.

        -  We estimate that the accrual rate will be 3-10 patients per month; the total accrual
           period for this study will be 10 months to 3 years.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Lesions Detected Using the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) Scan

Secondary Outcome

 Mean Radiation Activity Between Low Grade and Intermediate Grade Neuroendocrine Tumor

Condition

Neuroendocrine Tumors

Intervention

68Gallium DOTATATE

Study Arms / Comparison Groups

 68Gallium DOTATATE imaging
Description:  68Gallium DOTATATE imaging

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

341

Start Date

October 18, 2013

Completion Date

March 12, 2018

Primary Completion Date

December 17, 2017

Eligibility Criteria

        -  INCLUSION CRITERIA:

          -  Patients with (any one of #1, #2, and/or #3):

               1. Suspicion of neuroendocrine tumors (NET) on axial imaging (computed tomography
                  (CT)/magnetic resonance imaging (MRI)/fluorodeoxyglucose (FDG) positron emission
                  tomography (PET) and/or

               2. biochemical evidence of neuroendocrine tumor (serum/urinary) based on elevated
                  levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase,
                  vasoactive intestinal polypeptide, serotonin (urinary 5-HIAA), gastrin,
                  somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin,
                  C-peptide (proinsulin), glucagon and/or

               3. familial predisposition to NET in patients with multiple endocrine neoplasia type
                  1 (MEN1) and Von Hippel-Lindau (VHL) (symptomatic and/or asymptomatic cases; with
                  biochemical or anatomic imaging evidence of disease).

          -  Age greater than or equal to 10 years of age.

          -  For females: Negative urine pregnancy test OR post-menopausal for at least 2 years OR
             patient has had a hysterectomy.

          -  Patients must be willing to return to National Institutes of Health (NIH) for
             follow-up.

          -  Ability of subject or Legally Authorized Representative (LAR) (if the patient is
             deemed by the treating physician to be cognitively impaired or questionably impaired
             in such a way that the ability of the patient to give informed consent is
             questionable) to understand and the willingness to sign a written informed consent
             document indicating that they are aware of the investigational nature of this study.

        EXCLUSION CRITERIA:

          -  Patients unwilling to undergo serial non-invasive imaging.

          -  Pregnant or lactating women: Pregnant women are excluded from this study because the
             effects of (68)Ga-DOTATATE in pregnancy are not known. Because there is an unknown but
             potential risk for adverse events in nursing infants secondary to administration of

             (68)Ga-DOTATATE in the mother, breastfeeding should be discontinued for at least one
             day if the mother receives (68)Ga-DOTATATE.

          -  Patients that have recognized concurrent active infection,

          -  Patients with the use of any investigational product or device, excluding
             18F-dihydroxyphenylalanine (F-DOPA) scans, within 30 days prior to dosing.
      

Gender

All

Ages

10 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

Naris Nilubol, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01967537

Organization ID

130193

Secondary IDs

13-C-0193

Responsible Party

Principal Investigator

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Naris Nilubol, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

November 2019