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Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract

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ClinicalTrials.gov Identifier: NCT04069299
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Advanced Accelerator Applications
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.

Condition or disease Intervention/treatment
Neuroendocrine Carcinoma Drug: 68Ga-DOTATATE Diagnostic Test: Positron Emission Tomography (PET) Scan

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Somatostatin Receptor Expression in Poorly-Differentiated Neuroendocrine Carcinomas of the GI Tract: Analysis Using 68Ga-dotatate PET Scan
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021


Group/Cohort Intervention/treatment
Participants receiving PET scan
Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract
Drug: 68Ga-DOTATATE
The NETspot kit is 2 vials, Vial 1 contains 40 mcg dotatate, 5 mcg 1,10phenanthroline; 6mcg gentisic acid and 20 mg mannitol. Vial 2 contains 60 mg formic acid, 56.5 mg sodium hydroxide and water for injection
Other Name: NETspot

Diagnostic Test: Positron Emission Tomography (PET) Scan
PET scan is an imaging test using radioactive tracers.




Primary Outcome Measures :
  1. Percentage of Participants with Uniformly Positive 68Ga-dotatate PET [ Time Frame: Up to 10 months ]
    Percentage of participants with uniformly positive 68Ga-dotatate PET (positivity defined as SUV uptake > liver for all tumors at least 1cm in size). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.


Secondary Outcome Measures :
  1. Percentage of Participants with No Uptake to Very High Uptake on PET [ Time Frame: Up to 10 months ]
    Percentage of Participants with no uptake, heterogeneous uptake (tumors showing substantial differences in Somatostatin receptor [SSTR] uptake), low uptake (max SUV≤ liver), moderate uptake (liver<max SUV ≤2x liver, high uptake (max SUV > 2x liver), very high uptake (max SUV≥ kidney or spleen). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of Moffitt Cancer Center's GI Clinic
Criteria

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female ≥ 18 years old
  • Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
  • Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors >1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors >1cm).

Exclusion Criteria:

  • Participants with well-differentiated neuroendocrine tumors
  • Participants who have undergone 68Ga-dotatate PET scan in the past
  • Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069299


Locations
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United States, Florida
H Lee Moffitt Cancer & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Taymeyah Al-Toubah    813-745-6454    Taymeyah.Al-Toubah@moffitt.org   
Principal Investigator: Jonathan Strosberg, MD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Advanced Accelerator Applications
Investigators
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Principal Investigator: Jonathan Strosberg, MD H Lee Moffitt Cancer & Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04069299     History of Changes
Other Study ID Numbers: MCC-19943
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue