Clinical Trials Logo

Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT02358018
Other study ID # 14-226
Secondary ID
Status No longer available
Phase N/A
First received February 3, 2015
Last updated November 1, 2016

Study information

Verified date November 2016
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial Summary

The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan, instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor. 68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the USA, with better tumor detection than with OctreoScan.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 5 Years and older
Eligibility Inclusion Criteria:

- Patients diagnosed or suspected NET requiring 111In-pentetreotide imaging for clinical indications.

- High risk of NET because of familial predisposition with clinical findings requiring radiolabeled somatostatin imaging.

- Other somatostatin positive tumor for which 111In-pentetreotide has been used successfully (for example adult meningioma).

- Ability of subject or Legally Authorized Representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

- Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in pregnancy are not known; exceptions may be performed if expected risk outweighs the benefit. Pregnancy testing will follow MITS procedure for diagnostic reagents. Patients self report pregnancy status. If pregnant the test will not be performed unless in the clinical opinion of the attending physician the gain of the test is likely to outweigh the risk (this will be rare). If unsure whether pregnant or not then a urine or serum pregnancy will be performed.

- Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68Ga-DOTATOC in the mother, breastfeeding should be discontinued for at least one day if the mother receives 68Ga-DOTATOC.

- Patients that have contraindications for 111In-pentetreotide.

- Known severe allergy or hypersensitivity to oral contrast will preclude administration of such contrast (will preclude receiving oral contrast only).

- Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.

- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
68Ga-DOTATOC PET/CT Scan
Study participants will undergo the 68Ga-DOTATOC PET/CT after informed consent. The nominal injected dose will be up 3-5.5 mCi containing approximately 10 - 50 microgram of 68Ga-DOTATOC and will be injected via IV access lines. CT scans will be performed with our standard oral contrast agent (typically Omnipaque and/or barium) in accordance with our standard FDG practice unless some contraindication is present. Uptake period following injection will be 0.75-1hour. Acquisition time will be approximately ~1 hour. In patients who may not be able to lie still, anesthesia will be provided as per routine standard clinical practice.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT01218555 - Study of Everolimus (RAD001) in Combination With Lenalidomide Phase 1
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Withdrawn NCT04614766 - A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors Phase 1/Phase 2
Recruiting NCT05556473 - F-Tryptophan PET/CT in Human Cancers Phase 1
Completed NCT03273712 - Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC) Phase 2
Recruiting NCT05636618 - Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors Phase 1/Phase 2
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Completed NCT02815969 - The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors
Completed NCT02441062 - Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors Phase 2
Active, not recruiting NCT02174549 - Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer Phase 1/Phase 2
Completed NCT02134639 - PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation N/A
Completed NCT02132468 - A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers Phase 2
Recruiting NCT01201096 - Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors (NEO-LEBE) N/A
Terminated NCT01163526 - Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies N/A
Completed NCT01099228 - Combination Targeted Radiotherapy in Neuroendocrine Tumors N/A
Completed NCT00171873 - Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut Phase 3
Active, not recruiting NCT05077384 - Open-label Study of Surufatinib in Japanese Patients Phase 1/Phase 2
Active, not recruiting NCT04544098 - Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver Early Phase 1
Active, not recruiting NCT02736500 - Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors Phase 1/Phase 2