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Prospective observational cohort study for parameters from positron emission tomography magnetic resonance imaging (PET/MRI) in predicting the short-term efficacy and clinical prognostic efficacy of nasopharyngeal carcinoma

Prospective observational cohort study for parameters from positron emission tomography magnetic resonance imaging (PET/MRI) in predicting the short-term efficacy and clinical prognostic efficacy of nasopharyngeal carcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045482
Enrollment
Unknown
Registered
2021-04-17
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nasopharyngeal carcinoma

Interventions

Sponsors

Sun Yat-Sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Physical fitness score 0~1 points; 2. Pathologically confirmed WHO type II and III nasopharyngeal carcinoma; patients who have not received anti-tumor therapy for the first time and have no history of other malignant tumors; 3. The 8th edition of AJCC staging I-IVA stage; 4. Perform the following laboratory tests to evaluate bone marrow hematopoietic function, liver and kidney function within 14 days before enrollment. There are no contraindications to radiotherapy and chemotherapy: (1) White blood cell count >= 4 x 10^9/L, hemoglobin concentration >= 80g/L, platelet count >= 100 x 10^9/L; (2) Total bilirubin =< 1.5 times the upper limit of normal (ULN); (3) Alanine aminotransferase and aspartate aminotransferase < 2 x ULN, prothrombin time (PT) international standardized ratio/prothrombin time (PTT) < 1.5 x ULN, serum creatinine <1.5 x ULN; 5. Able to withstand MRI examinations and have good compliance; 6. Sign informed consent and have the ability and willingness to accept nuclear medicine examinations.

Exclusion criteria

Exclusion criteria: 1. Suffering from severe claustrophobia/high fever/dyspnea who cannot lie on their back/mentally abnormal and cannot cooperate; 2. Pregnant or lactating female patients: Women of childbearing age must take a pregnancy test within the first 7 days of treatment to exclude pregnancy. Male and female patients participating in this study must take the test during the test and two weeks after the end of the test. Adequate barrier contraceptive measures for contraception; 3. Unable to cooperate with regular follow-up due to psychological, social, family and geographic reasons; 4. Accompanied by serious uncontrollable infections or medical diseases; 5. Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, unable to tolerate radiotherapy and chemotherapy; 6. There are factors affecting administration, distribution, metabolism, excretion, etc., such as mental disorders, central nervous system abnormalities, chronic diarrhea, ascites, pleural fluid, etc.

Design outcomes

Primary

MeasureTime frame
Accuracy of short-term efficacy prediction;

Secondary

MeasureTime frame
Parameter index consistency evaluation;Sensitivity of short-term efficacy prediction;Specificity of short-term efficacy prediction;Predicted prognostic hazard ratio;Image acquisition time;Adverse Event;Sever Adverse Event;

Countries

China

Contacts

Public ContactLyu Xing

Sun Yat-Sen University Cancer Center

lvxing@sysucc.org.cn+86 15920182400

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026