Nasopharyngeal Carcinoma Clinical Trial
Official title:
Pilot Study of Somatostatin Receptor Imaging in Nasopharyngeal Cancer
| NCT number | NCT03670342 |
| Other study ID # | NPC SSTR |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 20, 2015 |
| Est. completion date | April 15, 2019 |
| Verified date | April 2020 |
| Source | National Cancer Centre, Singapore |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | April 15, 2019 |
| Est. primary completion date | April 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Singapore | National Cancer Centre | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Centre, Singapore | A*Star, Singapore General Hospital |
Singapore,
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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of NPC patients with high somatostatin receptor density | 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 | 60 minutes |
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