Clinical Trials /

Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors

NCT02441062

Description:

Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors. The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.

Related Conditions:
  • Malignant Solid Tumor
  • Neuroendocrine Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
  • Official Title: Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors

Clinical Trial IDs

  • ORG STUDY ID: 201503708
  • NCT ID: NCT02441062

Conditions

  • Neuroendocrine Tumors
  • Carcinoid Tumors
  • Neuroblastoma
  • Medulloblastoma

Interventions

DrugSynonymsArms
68Ga-DOTATOC PET/CT68Ga-DOTATOC PET/CT

Purpose

Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors. The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.

Detailed Description

      This is a prospective, Phase II, single center, open-label study in a total of 200
      participants with histologically proven neuroendocrine tumor or other somatostatin receptor
      positive tumors. Eligible participants will undergo baseline assessments at enrollment. They
      will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Participants may receive a
      second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first
      scan.
    

Trial Arms

NameTypeDescriptionInterventions
68Ga-DOTATOC PET/CTOtherStudy participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
  • 68Ga-DOTATOC PET/CT

Eligibility Criteria

        Inclusion Criteria:

          1. Signed informed consent

          2. Age ≥ 6 months

          3. Histologically diagnosed neuroendocrine tumor or other tumor with probable
             somatostatin receptors subtype 2

          4. Karnofsky performance status or Lansky Play Scale status of ≥ 60 (or ECOG/WHO
             equivalent)

          5. Subject is male; or is a female who is either surgically sterile (has had a
             documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (>
             1 years without menses), ≥60 years old,or of childbearing potential for whom a
             pregnancy test (with the results known prior to investigational product
             administration) is negative. A negative pregnancy test will be required for all
             female subjects with child bearing potential. If a false pregnancy test is suspected,
             e.g., perimenopausal condition, an obstetrician will be consulted to determine if she
             is/is not capable of becoming pregnant. Female must also be non-lactating.

        Exclusion Criteria:

          1. Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will
             not be able to fit inside the imaging machines) or otherwise cannot be safely fit
             into the imaging system.

          2. Inability to lie still for the entire imaging time (due to cough, severe arthritis,
             etc.)

          3. Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

          4. Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the investigator, may significantly interfere
             with study compliance.

          5. Peptide receptor radionuclide therapy (PRRT) within 4 weeks of Ga-68 DOTATOC PET/CT
             scan.

          6. Treatment with Sandostatin LAR within 4 weeks, SQ Octreotide within 12 hours, or
             Lanreotide injection within 8 weeks of Ga-68 DOTATOC PET/CT (+/-5%).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:6 Months
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluate impact of 68Gallium-DOTATOC PET/CT imaging on tumor management
Time Frame:36 months
Safety Issue:
Description:Referring physicians will be asked to fill out pre-PET and post-PET scan forms to provide information on the management and treatment strategy of the patient before the PET-CT scan and after the information from the PET-CT study is available. This is the same methodology used in the National Oncologic PET Registry study; change in management strategy criteria are modified for the specific treatment strategies used in NET (Table 2).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:O'Dorisio, M S

Last Updated

June 17, 2016