68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)

Last updated: August 4, 2025
Sponsor: Radio Isotope Therapy of America
Overall Status: Completed

Phase

N/A

Condition

Abdominal Cancer

Neuroendocrine Carcinoma

Digestive System Neoplasms

Treatment

111In-pentetreotide OctreoScan

PET/CT

68Ga-DOTATATE

Clinical Study ID

NCT01879657
117289
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent

  • Subjects of either sex, aged ≥18 years

  • Histologically and/or clinically confirmed and/or suspected NET and/or A diagnosticimaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bonescan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks ofdosing day

  • Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L,Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN [ ULN forALT, AST and AP is 70, 20 and 20 Units/I respectively], Bilirubin: ≤3 times ULN [ULNfor total bilirubin is 1.3mg/dL]

  • Serum creatinine: Serum creatinine: <170 μmol/L

  • egative pregnancy test in women capable of child-bearing

Exclusion

Exclusion Criteria:

  • Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of theexcipients of 68Ga-DOTATATE

  • Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is onSandostatin® LAR a wash-out phase of 28 days is required before the injection of thestudy drug

  • Pregnant or breast-feeding women

  • Current somatic or psychiatric disease/condition that may interfere with theobjectives and assessments of the study

Study Design

Total Participants: 169
Treatment Group(s): 4
Primary Treatment: 111In-pentetreotide OctreoScan
Phase:
Study Start date:
March 01, 2013
Estimated Completion Date:
December 05, 2017

Study 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.

Connect with a study center

  • Radio- Isotope Therapy of America

    Houston, Texas 77042
    United States

    Site Not Available

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