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Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT

S

Sue O'Dorisio

Status and phase

Completed
Phase 2

Conditions

Adult Medulloblastoma
Neuroblastoma
Somatostatinoma
Childhood Medulloblastoma
Neuroendocrine Tumor

Treatments

Procedure: computed tomography
Procedure: positron emission tomography/computed tomography
Radiation: indium In 111 pentetreotide
Procedure: contrast-enhanced magnetic resonance imaging
Drug: gallium Ga 68-edotreotide

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01869725
NCI-2013-00936 (Registry Identifier)
R01CA167632 (U.S. NIH Grant/Contract)
P30CA086862 (U.S. NIH Grant/Contract)
201212736

Details and patient eligibility

About

This clinical trial studies gallium Ga 68-edotreotide positron emission tomography (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of patients with neuroendocrine tumors.

Full description

PRIMARY OBJECTIVES:

I. To compare efficacy of [68Ga]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga 68-edotreotide) PET/CT with Octreoscan (indium In 111 pentetreotide) + high-resolution, contrast-enhanced CT for diagnosis and staging in patients with somatostatin receptor expressing tumors.

OUTLINE:

Patients receive gallium Ga 68-edotreotide intravenously (IV) and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may also undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.

Enrollment

68 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent
  • Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or other somatostatin receptor positive tumor
  • Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off immediate release (subcutaneous) for 12 hrs prior to 68Ga-DOTATOC PET-CT
  • Karnofsky performance status or Lansky Play Scale status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
  • Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative; a negative serum 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 capable of becoming pregnant
  • No therapy other than Sandostatin since last Octreoscan + diagnostic CT
  • Fresh frozen (recommended) or paraffin fixed (required) specimen of primary or metastases available for ribonucleic acid (RNA) and immunohistochemistry (IHC)

Exclusion criteria

  • Pregnancy or breast feeding
  • Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed
  • Medical condition uncontrolled by treatment making completion of study unlikely
  • Weight more than 400 pounds (subjects who weigh more than 400 pounds will not be able to fit inside the imaging machines)
  • Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

68 participants in 1 patient group

Diagnostic (gallium Ga 68-edotreotide PET/CT)
Experimental group
Description:
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.
Treatment:
Drug: gallium Ga 68-edotreotide
Procedure: contrast-enhanced magnetic resonance imaging
Radiation: indium In 111 pentetreotide
Procedure: computed tomography
Procedure: positron emission tomography/computed tomography

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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