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Pilot Study of Somatostatin Receptor Imaging in Nasopharyngeal Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03670342
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 27, 2018
Singapore General Hospital
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Brief Summary:

Hypothesis: To estimate the proportion of locally advanced, recurrent or metastatic nasopharyngeal cancer patients which show high somatostatin receptor density (SUVmax >10) on Ga-68 DOTATATE imaging.

Galium-68 DOTATATE: PET imaging will be performed with a PET/CT scanner. Galium-68 DOTATATE will be injected intravenously. Scanning will be performed approximately 60 minutes after the injection.

The standardized uptake value (SUV) will be used in the interpretation of the Ga-68 DOTATATE scans. The values gathered will be used as an estimate of the somatostatin receptor density. A patient will be considered to have an overall high somatostatin receptor density if the average SUVmax of all the representative lesions is more than 10.

Condition or disease
Nasopharyngeal Carcinoma

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study of Somatostatin Receptor Imaging in Nasopharyngeal Cancer
Actual Study Start Date : August 20, 2015
Estimated Primary Completion Date : August 20, 2020
Estimated Study Completion Date : August 20, 2025

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Number of NPC patients with high somatostatin receptor density [ Time Frame: 60 minutes ]
    High somatostatin receptor density is when average maximum standardized uptake value (SUVmax) of all the representative lesions is more than 10 on Ga-68 DOTATATE imaging

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients would have to have histologically confirmed nasopharyngeal cancer and are above 21 years of age.

Inclusion Criteria:

  • Locally advanced NPC or Metastatic NPC or locally recurrent NPC
  • >21 years old
  • Histological confirmation of NPC

Exclusion Criteria:

  • <21 years old
  • Pregnancy or breast feeding

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 identifier (NCT number): NCT03670342

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Contact: Wen Long Nei +65 6436 8000

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National Cancer Centre Recruiting
Singapore, Singapore, 169610
Sponsors and Collaborators
National Cancer Centre, Singapore
Singapore General Hospital
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Principal Investigator: Wen Long Nei National Cancer Centre, Singapore

Additional Information:
Nei WL, Jain A, Wang FQ, Khor LK, Yeong JP, Han ST, Sommat K, Ang MK, Soong YL, Loke KSH. Somatostatin receptor imaging in nasopharyngeal cancer. Ann Nasopharynx Cancer 2018;2:2

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Responsible Party: National Cancer Centre, Singapore Identifier: NCT03670342     History of Changes
Other Study ID Numbers: NPC SSTR
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs