Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

68-Ga-DOTATATE PET-CT Scan for Diagnosis and Staging of Neuroendocrine Tumors

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: NCT01879657
Recruitment Status : Unknown
Verified August 2015 by Ebrahim Delpassand, Radio Isotope Therapy of America.
Recruitment status was:  Recruiting
First Posted : June 18, 2013
Last Update Posted : August 13, 2015
Sponsor:
Collaborators:
Radiomedix, Inc.
Excel Diagnostics and Nuclear Oncology Center
Information provided by (Responsible Party):
Ebrahim Delpassand, Radio Isotope Therapy of America

Brief Summary:
To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like CT scan/MRI as gold standard.

Condition or disease Intervention/treatment Phase
Neuroendocrine Carcinoma Drug: 68Ga-DOTATATE PET scan Phase 1 Phase 2

Detailed Description:
The number of lesions that could be identified clearly as single foci will be determined for each patient. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection. Because of confluence and inability to clearly delineate single liver lesions in some cases, liver metastases will be classified as 1 organ metastasis, independent of the number of liver metastases present. Lymph nodes smaller than 1 cm on CT or MRI and showing marked avidity for 68Ga- DOTATATE and 111In-penteoctreotide will be labeled as positive for disease. The presence of lesions will be confirmed by cross-sectional imaging of all patients with CT or MRI.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68-Ga-DOTATATE PET-CT Scan for Diagnosis and Staging of Neuroendocrine Tumors
Study Start Date : March 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : August 2016


Arm Intervention/treatment
Experimental: 68Ga-DOTATATE PET scans

Will perform 68Ga-DOTATATE PET scans on subjects. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection.

The images from 68Ga-DOTATATE PET/CT will be reported by an experienced nuclear medicine physician who will be unaware of the results of the previous 111Inpenteoctreotide study. Areas of abnormal focal uptake will be documented. These areas of abnormal uptake will be compared with cross-sectional imaging (CT or MRI)to confirm the presence of lesions. The images from 111In- penteoctreotide Scintigraphy will be reported independently by another experienced nuclear medicine physician.

Drug: 68Ga-DOTATATE PET scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.




Primary Outcome Measures :
  1. Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique [ Time Frame: one year ]
    We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of either gender, aged at least 18 years.
  • Karnofsky status equal or greater than 60.
  • Life expectancy of at least 12 weeks.
  • Histologically and/or clinically confirmed and/or suspicious of NET.
  • Somatostatin-analogue scintigraphies scan with result (positive or negative) within the last 4 weeks.
  • Recent Blood test results up to 2-3 weeks as follows:(WBC:equal/higher 2*109/L; Haemoglobin: equal/higher 8.0g/Dl; Platelets: equal/higher 50x109/L; ALT, AST, AP: equal/lower 5 times ULN; Bilirubin: equal/lower 3 times ULN; Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or older.
  • Negative pregnancy test in women capable of child-bearing.

Exclusion Criteria:

  • Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE.
  • Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug.
  • Pregnant or breast-feeding women.
  • Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.

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): NCT01879657


Contacts
Layout table for location contacts
Contact: Ebrahim S Delpassand, MD 713-499-9733 edelpassand@radiomedix.com
Contact: Izabela Tworowska, PhD 7135900601 itworowska@radiomedix.com

Locations
Layout table for location information
United States, Texas
Radio- Isotope Therapy of America Recruiting
Houston, Texas, United States, 77042
Contact: Ebrahim S Delpassand, MD         
Principal Investigator: Ebrahim S Delpassand, MD         
Sponsors and Collaborators
Radio Isotope Therapy of America
Radiomedix, Inc.
Excel Diagnostics and Nuclear Oncology Center
Investigators
Layout table for investigator information
Principal Investigator: Ebrahim Delpassand, MD Radiomedix, Inc.

Layout table for additonal information
Responsible Party: Ebrahim Delpassand, President, Radio Isotope Therapy of America
ClinicalTrials.gov Identifier: NCT01879657     History of Changes
Other Study ID Numbers: 117289
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial