Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-20

Study Completion Date

2020-12-20

Brief Summary

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NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously in the follow-up of Locally Advanced Nasopharyngeal Carcinoma. Hence we establish this prospective cohort study.

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Detailed Description

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Newly-diagnosed patients with stage III or IV non-metastatic Nasopharyngeal Carcinoma (AJCC 8th) will be recruited. All subjects receiving chemoradiotherapy will undergo a baseline integrated \[18F\]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan or traditional follow-up examination before the start of chemoradiotherapy.

NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously 12 weeks after the end of chemoradiotherapy (primary endpoint).

The results of FDG PET/CT and high-sensitivity PET/CT analyzed and compared.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PET CT and ultrasensitive PET CT

Patients receiving chemoradiotherapy will receive a dedicated FDG PET/CT and ultrasensitive PET CT protocol 12 weeks after the end of IMRT .

ultrasensitive PET CT

Intervention Type DEVICE

A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER), has been constructed to offer a transformative platform for human radiotracer imaging in clinical research and healthcare. Its total-body coverage and exceptional sensitivity provide opportunities for innovative studies of physiology, biochemistry, and pharmacology.

Interventions

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ultrasensitive PET CT

A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER), has been constructed to offer a transformative platform for human radiotracer imaging in clinical research and healthcare. Its total-body coverage and exceptional sensitivity provide opportunities for innovative studies of physiology, biochemistry, and pharmacology.

Intervention Type DEVICE

Other Intervention Names

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PET CT

Eligibility Criteria

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Inclusion Criteria

* Patients must be informed of the investigational nature of this study and given written informed consent.
* Aged between 18-70, male/female.
* Staged III or IV (AJCC 8th) NPC patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III).
* Received induction chemotherapy and/or concurrent chemoradiotherapy. ECOG scale 0-1.
* Fertile women should practice contraception during the study period.
* HGB ≥90g/L ,WBC ≥4\*109/L , PLT ≥100\*109/L,
* With normal liver function test (ALT and AST ≤2.5\*ULN, TBil ≤2.0\*ULN)
* With normal renal function test (serum creatinine ≤1.5\*ULN)

Exclusion Criteria

* Women in pregnancy or lactation
* Prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
* Already involved in other clinical trial.
* Mental disorder, civil disability, limited capacity for civil conduct.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No