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

Phase 1/Phase 2
18 Years
60 Years
Open (Enrolling)
Neuroendocrine Carcinoma

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique

Outcome Description:

We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Ebrahim Delpassand, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

March 2014

Related Keywords:

  • Neuroendocrine Carcinoma
  • Carcinoma
  • Carcinoma, Neuroendocrine
  • Neuroendocrine Tumors



Radio- Isotope Therapy of America Houston, Texas  77042