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ISRCTN
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ISRCTN94329628
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ClinicalTrials.gov identifier
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Public title
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99mTc-3PRGD2 SPECT/CT for response evaluation of lung cancer
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Scientific title
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A multicenter clinical study of 99mTc-3PRGD2 SPECT/CT in an early response evaluation of lung cancer to chemotherapy and molecular-targeted therapy
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Acronym
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N/A
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Serial number at source
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2012-01
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Study hypothesis
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A group of clinically diagnosed lung cancer patients by 99mTc-3PRGD2 SPECT / CT and 18F-FDG PET / CT before treatment, treatment of early and late after the end of treatment or imaging to monitor tumor, treatment effect. According to PERICST standard in the evaluation of therapeutic effect.
We plan to compare 99mTc-3PRGD2 SPECT / CT with 18F-FDG PET/CT for response evaluation of lung cancer. The latter generally used “PET Response Criteria in Solid Tumors (PERCIST)” for response evaluation
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Lay summary
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Lay summary under review 1
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Ethics approval
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Peking Union Medical College Hospital, 16 November 2010, ref: S336
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Study design
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Prospective study design
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Countries of recruitment
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China
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Disease/condition/study domain
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Lung cancer
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Participants - inclusion criteria
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1. Age of 30 - 70 years
2. Clinical pathology in patients with lung cancer
3. Patients without radiotherapy
4. Radiation therapy
5. The clinical plan complete regimen in the treatment of patients
6. Can follow up the survival period of patients
7. Can obtain complete evaluation of the efficacy of imaging data before and after treatment
8. Volunteered to participate in and signed informed consent
Clinical diagnosis of pulmonary primary tumor, and without chemotherapy, radiotherapy patients, histologic type is not restricted. Clinical chemotherapy scheme is not restricted. Requirements of each patient in chemotherapy before a week, the first course of chemotherapy after the second chemotherapy was started 1 weeks prior to, and during the first chemotherapy 3 months after the start of the three time points respectively imaging ( including CT, MR and / or US control imaging ). If the patients during the treatment period replacement therapy must be recorded in detail. Requirements for follow-up each survival in patients with stage.
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Participants - exclusion criteria
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1. Withdrawal of informed consent
2. Loss to follow-up
3. Against research programme
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Anticipated start date
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01/02/2012
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Anticipated end date
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01/02/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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More than 200 cases
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Interventions
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Single treatment arm will be used. Methodology: 99mTc-3PRGD2 SPECT/CT scans.
This is a diagnostic, single group assignment, open label efficacy study. Three 99mTc-3PRGD2 SPECT/CT scans will be performed at baseline, post one cycle, and post 3 cycles of treatment, respectively for each patient. 99mTc-3PRGD2 will be intravenously injected 40 minutes before each scan. The dose is 0.3 mCi / Kg body weight (± 5%). Follow-ups will be performed every 3 months until the end of the study.
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Primary outcome measure(s)
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1. Changes of 99mTc-3PRGD2 uptake after one cycle of therapy compared to that after three cycles.
2. Determine if the early uptake changes of 99mTc-3PRGD2 after one cycle of therapy compared to the baseline can reflect that of three cycles later.
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Secondary outcome measure(s)
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1. Changes of 99mTc-3PRGD2 uptake compared to those of CT and/or PET/CT.
2. Determine if the 99mTc-3PRGD2 evaluations either post one cycle or post three cycles of treatment is better than or comparable to those of CT according to the RECIST criteria and/or PET/CT evaluations using PERCIST criteria.
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Sources of funding
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1. Capital Special Project (China) ref: Z111107058811096
2. National Natural Science Foundation (China)
3. Ministry of Science and Technology (China) ref: 2009ZX09103-733
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Trial website
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Publications
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Contact name
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Prof
Fang
Li
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Address
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Department of Nuclear Medicine
Peking Union Medical College Hospital
No 1 Shuaifuyuan
Wangfujing Street
Dongcheng District
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City/town
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Beijing
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Zip/Postcode
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100730
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Country
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China
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Sponsor
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National Natural Science Foundation [NSFC] (China)
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Address
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83 Shuangqing Road
Haidian Area
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City/town
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Beijing
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Zip/Postcode
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100085
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Country
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China
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Sponsor website:
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http://www.nsfc.gov.cn/nsfc/
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Date applied
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20/01/2012
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Last edited
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03/02/2012
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Date ISRCTN assigned
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03/02/2012
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