99mTc-3PRGD2 SPECT/CT for response evaluation of lung cancer
| ISRCTN | ISRCTN94329628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94329628 |
| Protocol serial number | 2012-01 |
| Sponsor | National Natural Science Foundation (China) |
| Funders | Capital Special Project (China) ref: Z111107058811096, National Natural Science Foundation of China, Ministry of Science and Technology of the People's Republic of China (ref: 2009ZX09103-733) |
- Submission date
- 20/01/2012
- Registration date
- 03/02/2012
- Last edited
- 02/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Integrin αⅤβ3 is a receptor that is found on various types of tumor cell but not on (or very low on) normal cells. Therefore, it is becoming a valuable target for the diagnosis of tumors and monitoring the effects of treatment. Arginine-glycine-aspartic acid (RGD) can specifically bind to the integrin αⅤβ3 receptor. A variety of radioactively labeled (radiolabeled) RGD-based peptides have been developed for detecting integrin avb3 by positron emission tomography (PET) or single photon emission computed tomography (SPECT) scans. Among all the RGD radiotracers studied, 18F-Galacto-RGD and 18F-AH111585 have been well investigated and the results demonstrated that both radiotracers could be used to detect various types of tumors. Recently, new 99mTc-labeled RGD dimeric peptides have showed much higher binding to integrin avb3 and increased tumor uptake. 99mTc-3PRGD2 has been tested in lung cancer patients, appeared to be useful for diagnosis, and no side effects have been observed to date. The aim of this study is to assess the effectiveness of 99mTc-3PRGD2 for evaluating the early response of lung cancer to treatment.
Who can participate?
Patients aged 30 to 70 with lung cancer who are undergoing chemotherapy and/or molecular targeted treatment for at least 3 cycles or 3 months without radiotherapy
What does the study involve?
The study involves three 99mTc-3PRGD2 SPECT/CT scans at the start of the study, after one cycle, and after three cycles of treatment, respectively. An early evaluation after one cycle of therapy is compared with a standard evaluation after three cycles, and the new method is compared with CT and 18F-FDG PET/CT scans for evaluation.
What are the possible benefits and risks of participating?
Participants receive free 99mTc-3PRGD2 SPECT/CT scans and detailed medical follow-up. Participants are exposed to radiation from the low-dose CT and radiotracers. Possible side effects to the tracer 99mTc-3PRGD2 may occur, although no side effects have been observed to date.
Where is the study run from?
Peking Union Medical College Hospital (China)
When is the study starting and how long is it expected to run for?
February 2012 to February 2013
Who is funding the study?
1. Capital Special Project (China)
2. National Natural Science Foundation (China)
3. Ministry of Science and Technology (China)
Who is the main contact?
Prof. Fang Li
Contact information
Scientific
Department of Nuclear Medicine
Peking Union Medical College Hospital
No 1 Shuaifuyuan
Wangfujing Street
Dongcheng District
Beijing
100730
China
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective study design |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | A multicenter clinical study of 99mTc-3PRGD2 SPECT/CT in an early response evaluation of lung cancer to chemotherapy and molecular-targeted therapy |
| Study objectives | 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. The aim of this study is 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 |
| Ethics approval(s) | Peking Union Medical College Hospital, 16/11/2010, ref: S336 |
| Health condition(s) or problem(s) studied | Lung cancer |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Changes of 99mTc-3PRGD2 uptake after one cycle of therapy compared to that after three cycles |
| Key secondary outcome measure(s) |
1. Changes of 99mTc-3PRGD2 uptake compared to those of CT and/or PET/CT |
| Completion date | 01/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 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. |
| Key exclusion criteria | 1. Withdrawal of informed consent 2. Loss to follow-up 3. Against research programme |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 01/02/2013 |
Locations
Countries of recruitment
- China
Study participating centre
100730
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/11/2017: Internal review.
30/06/2017: Plain English summary added.
