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Prospective study of 18F-FMISO hypoxia imaging to predict radiotherapy efficacy in non-small cell lung cancer

Prospective study of 18F-FMISO hypoxia imaging to predict radiotherapy efficacy in non-small cell lung cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070902
Enrollment
Unknown
Registered
2023-04-26
Start date
2017-09-14
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

non-small cell lung cancer

Interventions

photon radiotherapy group:18F-MISO/PETCT scanning,photon radiotherapy
carbon-ion radiotherapy group:18F-MISO/PETCT scanning, carbon-ion radiotherapy

Sponsors

Shanghai Proton and Heavy Ion Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Sign informed consent; 2) Age =18 years old; 3) Have the ability to comply with the scheme; 4) cytological or histological identification of lung lesions is required; 5) Non-small cell lung cancer confirmed by cytology or histology; T=3cmN0-3M0 (UICC/AJCC 8th edition); 6) Patients who cannot (after thoracic surgery evaluation) for medical reasons, or patients who refuse surgery, willing to receive carbon ion or photon radiotherapy; 7) Patients who need synchronous chemotherapy in principle but cannot tolerate or refuse synchronous chemotherapy due to medical reasons; 8) KPS score is greater than or equal to 60, ECOG general status score is 0-1 (at least can walk around freely and take care of themselves, and can get up and do activities for at least half of the day); 9) The expected survival period is greater than or equal to 12 months; 10) Adequate organ function to meet the basic requirements for the treatment required.

Exclusion criteria

Exclusion criteria: ) The patient's disease has not been confirmed by pathology; 2) Complicated with other malignant tumors and has not been controlled; 3) The toxic and side effects of previous treatment have not recovered, such as systemic chemotherapy or targeted therapy and other anti-cancer treatment interval <1 month; 4) Patients for whom the radiotherapy plan fails to meet the minimum target dose coverage and dose volume limits, or fails to meet the dose limits of normal organs; 5) Have received thoracic radiotherapy or radioactive particle implantation in the past; (6) Pacemakers or other metal implants that may be affected by high-energy radiation interference with normal function or that may affect radiation target dose; 7) pregnancy (confirmed by serum or urine ß-HCG test) or lactation; 8) Being HIV positive, including having taken antiretroviral therapy; Chronic hepatitis B virus replication stage; Hepatitis C active phase; Active stage of syphilis; 9) HBV positive patients with hepatitis virus replication stage need to receive antiviral therapy, but cannot receive antiviral therapy because of the accompanying disease; 10) With severe comorbidities that may affect radiotherapy, including: a) acute infectious diseases; Or the acute active phase of chronic infection; b) Unstable angina pectoris, congestive heart failure, myocardial infarction requiring hospitalization in the past 6 months; c) hospitalization for exacerbations of COPD or other respiratory diseases; d) severely impaired immune function; e) Hypersensitivity to radiation, such as ataxia telangiectasia; f) being pregnant or lactating; g) Other diseases that may affect particle therapy; 11) having no or limited capacity for civil conduct; 12) Drug abuse or alcohol dependence, or a history of mental illness, who cannot understand the treatment or the purpose of this study or may hinder the completion of treatment; 13) Unwilling/unable to sign informed consent; 14) Situations in which other physicians consider it inappropriate to participate in clinical studies.

Design outcomes

Primary

MeasureTime frame
local control rate;

Secondary

MeasureTime frame
progression-free survival rate;cause-specific survival rate;overall survival rate;disease-free survival rate;

Countries

China

Contacts

Public ContactJingfang Mao, Jian Chen, Jiade Lu

Shanghai Proton and Heavy Ion Center

jingfang.mao@sphic.org.cn+86 21 38296666

Outcome results

None listed

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