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

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Brief Title

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

Official Title

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

      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 Phase

Phase 1

Study Type


Primary Outcome

Change in size of lesion

Secondary Outcome

 Incidence of new lesions


Neuroendocrine Tumors



Study Arms / Comparison Groups

Description:  patients with known or suspected somatostatin receptor positive neuroendocrine tumors (NETs)


* 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


Estimated Enrollment


Start Date

December 2014

Completion Date

January 23, 2017

Primary Completion Date

January 23, 2017

Eligibility Criteria

        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

          -  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




18 Years - N/A

Accepts Healthy Volunteers



Lale Kostakoglu, MD, MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID

GCO 14-2008

Responsible Party


Study Sponsor

Lale Kostakoglu

Study Sponsor

Lale Kostakoglu, MD, MPH, Principal Investigator, Icahn School of Medicine at Mount Sinai

Verification Date

May 2017