Clinical trial NCT03670342: Pilot Study of Somatostatin Receptor Imaging in Nasopharyngeal Cancer
Official title: Pilot Study of Somatostatin Receptor Imaging in Nasopharyngeal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
name: A*Star
First posted: 2018-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients would have to have histologically confirmed nasopharyngeal cancer and are above 21 years of age.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of NPC patients with high somatostatin receptor density
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre
Study officials:
affiliation: National Cancer Centre, Singapore
name: Wen Long Nei
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: Lechner M, Schartinger VH, Steele CD, Nei WL, Ooft ML, Schreiber LM, Pipinikas CP, Chung GT, Chan YY, Wu F, To KF, Tsang CM, Pearce W, Morelli D, Philpott M, Masterson L, Nibhani R, Wells G, Bell CG, Koller J, Delecluse S, Yip YL, Liu J, Forde CT, Forster MD, Jay A, Dudas J, Krapp A, Wan S, Uprimny C, Sprung S, Haybaeck J, Fenton TR, Chester K, Thirlwell C, Royle G, Marafioti T, Gupta R, Indrasari SR, Herdini C, Slim MAM, Indrawati I, Sutton L, Fles R, Tan B, Yeong J, Jain A, Han S, Wang H, Loke KSH, He W, Xu R, Jin H, Cheng Z, Howard D, Hwang PH, Le QT, Tay JK, West RB, Tsao SW, Meyer T, Riechelmann H, Oppermann U, Delecluse HJ, Willems SM, Chua MLK, Busson P, Lo KW, Wollmann G, Pillay N, Vanhaesebroeck B, Lund VJ. Somatostatin receptor 2 expression in nasopharyngeal cancer is induced by Epstein Barr virus infection: impact on prognosis, imaging and therapy. Nat Commun. 2021 Jan 5;12(1):117. doi: 10.1038/s41467-020-20308-8.