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68Ga-Dotatoc Positron Emission Tomography (PET) for Somatostatin Receptor-Positive Neuroendocrine Tumors (NETs)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02359500
Recruitment Status : Terminated (compound no longer available)
First Posted : February 10, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Lale Kostakoglu, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE January 23, 2015
First Posted Date  ICMJE February 10, 2015
Last Update Posted Date May 3, 2017
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date January 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2015)
Change in size of lesion [ Time Frame: baseline and 1 month ]
Change in size of lesion at 1 month as compared to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2015)
  • Incidence of new lesions [ Time Frame: baseline and 1 month ]
    Number of new lesions at 1 month as compared to baseline
  • Incidence of change in treatment [ Time Frame: baseline and 1 month ]
    Change in treatment caused by result of 68Ga-DOTATOC PET/CT at 1 month as compared to baseline
  • Incidence of previously unknown primary tumor [ Time Frame: baseline and 1 month ]
    Incidence of identification of the location of a previously unknown primary tumor at 1 month as compared to baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 68Ga-Dotatoc Positron Emission Tomography (PET) for Somatostatin Receptor-Positive Neuroendocrine Tumors (NETs)
Official Title  ICMJE Safety and Efficacy Study of 68Ga-Dotatoc Positron Emission Tomography for Diagnosis for Staging, Restaging and Assessment of Response to Treatment in Somatostatin Receptor-Positive Neuroendocrine Tumors
Brief Summary This study plans to demonstrate the safety and efficacy of [68Ga]-DOTA-tyr3-Octreotide ([68Ga]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of response to treatment in patients with Somatostatin receptor expressing tumors who undergo imaging with a clinical indication. The investigators will conduct a study for 68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors. 68Ga-DOTATOC will be used in diagnostic assessment of patients with known or suspected NETs for whom there is an appropriate standard clinical indication for 68Ga-DOTATOC PET/CT either at staging or during follow up.
Detailed Description

Rationale and overall study design This study is planned to demonstrate the safety and efficacy of [68Ga]-DOTA-tyr3-Octreotide ([68Ga]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of response to treatment in patients with Somatostatin receptor expressing tumors who undergo imaging with a clinical indication.

Neuroendocrine tumors (NET) are rare neoplasms of neuroendocrine origin. Neuroendocrine tumors are solid malignant tumors that arise from dispersed neuroendocrine cells found throughout the body. They are well known for their heterogeneity which makes it difficult to obtain uniform clinical data and establish universal guidelines for the diagnosis and treatment of NETs. NETs are characterized by overexpression of somatostatin receptors, which can be visualized and targeted by radiolabeled somatostatin analogues. 111In-diethylenetriaminepentaacetic acid-octreotide scintigraphy (111In-Octreotide) with single photon emission tomography (SPECT) is currently the standard imaging modality for evaluating patients with NETs. 111In Octreotide is the only FDA approved radiopharmaceutical available on the market for assessing the extent of involvement by NETs at both staging and follow up periods. However, the sensitivity of this imaging modality is lower compared to the positron emission tomography (PET) radiotracer 68Ga-DOTA0-Tyr3]octreotide (68Ga-DOTA-TOC). Based on the improved sensitivity, 68Ga DOTATOC PET leads to significant changes in 30% of patients. Importantly, the radiation exposure of 68Ga-DOTATOC PET is lower than that of 111In Octreotide and also the imaging with 68Ga-DOTATOC PET scan yields fast read-outs on the same day compared to 24-48 hour read-outs with 111In Octreotide scan. These advantages make the 68Ga labeled somatostatin analog more attractive from both the patient and management perspectives. The improved resolution and quantitation of uptake obtained with Ga-68 DOTATOC PET should provide a more accurate assessment of somatostatin receptor density, which will lead to a more accurate prediction of treatment response to somatostatin analogues.

While the investment costs for the scanner, the radiochemistry equipment are higher for 68Ga-DOTATOC PET/CT compared with 111In-DTPA-octreotide scintigraphy and SPECT, with the provision of this imaging molecule by an established commercial radiopharmaceutical company that in with compliance to FDA 21 CFR Part 212 IBA Molecular Inc, NJ, USA, this will not pose a limitation for the Mount Sinai Medical Center. In this setting, 68Ga-DOTATOC PET/CT production and personnel costs will be borne by the commercial entity, however, Mount Sinai Medical Center will purchase the 68Ga-DOTATOC based on a per patient schedule. Since this imaging modality does not have a quote for reimbursement by the insurance carriers, the imaging cost is considered a potential burden on the patient until it is approved by the U.S. Food and Drug Administration (FDA). There is significant amount of European based clinical data (>1000 patients) to prove the safety and efficacy of this imaging agent, therefore, a phase II or III clinical trial in the US is redundant and will only delay the approval of this imaging probe. Recently, Ga-68 DOTATOC has been designated as an orphan drug by the FDA for the management of NET. This designation will probably lead to faster approval of the agent, which would greatly benefit NET patients in the US. Currently, there are only several small U.S.-based clinical trials for Ga-68 labeled NET PET agents available for patients; otherwise they must travel out of the country if the scan is required to manage their disease.

The investigators, therefore, aim to provide this superior imaging technique to NET patients for better disease management by the referring physicians, however, this objective cannot be attained unless at least a partial funding mechanism exists to make it affordable by the patients until the approval of this superior imaging probe. In this regard, the investigators are aiming at recovering the cost of the radiotracer from the local insurance carrier through the cost recovery system.

Participant Enrollment Participants will be recruited from the Mount Sinai Medical Center. Participants who will be approached regarding the study are those individuals who are being seen for known or suspected malignancies.

Patients may remain on their somatostatin therapies throughout the study with no management change merely based on the 68Ga -DOTATOC PET/CT imaging findings. The management of these patients will be based on the standard of care and any change will be at the discretion of the referring physician. All pertinent dosing information must be collected and reported.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Neuroendocrine Tumors
  • Carcinoid Tumors
Intervention  ICMJE Drug: 68Ga-DOTATOC PET
68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors.
Other Names:
  • [68Ga]-DOTA-tyr3-Octreotide
  • [68Ga]-DOTATOC
Study Arms  ICMJE Experimental: 68Ga-DOTATOC PET
patients with known or suspected somatostatin receptor positive neuroendocrine tumors (NETs)
Intervention: Drug: 68Ga-DOTATOC PET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 23, 2017)
71
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2015)
130
Actual Study Completion Date  ICMJE January 23, 2017
Actual Primary Completion Date January 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Known or suspected somatostatin receptor positive NETs (e.g. carcinoid, pancreatic neuroendocrine tumors, and pheochromocytoma). Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
  • Karnofsky performance status of ≥50 (or ECOG/WHO equivalent)
  • Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off immediate release (subcutaneous) for at least 12 hrs prior to 68Ga-DOTATOC PET-CT imaging
  • Able to provide informed consent
  • At least 18 years of age

Exclusion Criteria:

  • Pregnancy or breast feeding. A negative serum pregnancy test is required for all female subjects with child- bearing potential
  • Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed
  • Medical condition uncontrolled by treatment making completion of study unlikely
  • Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET/CT scanner due to Body Mass Index (BMI)
  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (e.g. severe claustrophobia)
  • Any additional medical condition, serious intercurrent illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02359500
Other Study ID Numbers  ICMJE GCO 14-2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lale Kostakoglu, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Lale Kostakoglu
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lale Kostakoglu, MD, MPH Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP