Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
NCT ID: NCT02441062
Last Updated: 2020-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
122 participants
INTERVENTIONAL
2015-09-30
2020-01-20
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga-DOTATOC PET/CT
Study 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
Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors
Interventions
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68Ga-DOTATOC PET/CT
Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors
Eligibility Criteria
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Inclusion Criteria
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
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%).
6 Months
ALL
No
Sponsors
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University of Iowa
OTHER
Sue O'Dorisio
OTHER
Responsible Party
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Sue O'Dorisio
Professor, Pediatrics Hematology/Oncology
Principal Investigators
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Mary S O'Dorisio, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Countries
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References
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Menda Y, Ponto LL, Schultz MK, Zamba GK, Watkins GL, Bushnell DL, Madsen MT, Sunderland JJ, Graham MM, O'Dorisio TM, O'Dorisio MS. Repeatability of gallium-68 DOTATOC positron emission tomographic imaging in neuroendocrine tumors. Pancreas. 2013 Aug;42(6):937-43. doi: 10.1097/MPA.0b013e318287ce21.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201503708
Identifier Type: -
Identifier Source: org_study_id