Malignant TumorsNCT07208487
Clinical Study of Pretreatment PET/CT Parameters for Predicting the Efficacy of 125I Seed Implantation in the Treatment of Malignant Tumors
An observational study of Malignant Tumors, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial summary
This study aimed to determine if pre-treatment 18F-FDG PET/CT metabolic parameters could predict the effectiveness of 125I seed implantation for malignant tumors. In a retrospective analysis of 41 patients with 69 lesions, various parameters were measured. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Tumors
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with malignant tumors who underwent 125I seed implantation therapy at the Department of Nuclear Medicine, Jiangxi Cancer Hospital between November 2019 and November 2023 and received preoperative 18F-FDG PET/CT scans.
Who may be able to join
- Interval between PET/CT imaging and 125I seed implantation ≤4 weeks; (2)CT follow-up performed 4 months post-125I seed implantation; (3) Primary tumor pathologically or cytologically diagnosed as malignant; (4) Metastatic or recurrent lesions implanted with 125I confirmed by cytological aspiration or imaging
Who cannot join
- Lesions too small or SUVmax < 2.5, rendering them unidentifiable by software for PET/CT parameter measurement; (2) Two 125I seed implantation procedures performed within 6 months for the same lesion; (3) Incomplete clinical or imaging data.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to determine if pre-treatment 18F-FDG PET/CT metabolic parameters could predict the effectiveness of 125I seed implantation for malignant tumors. In a retrospective analysis of 41 patients with 69 lesions, various parameters were measured. The results identified Metabolic Tumor Volume (MTV) as the most significant independent prognostic factor, outperforming other standardized uptake values (SUV) and ratios. A higher MTV was associated with a worse treatment outcome, suggesting it is a valuable predictor for guiding treatment decisions.
Read the detailed description
Objective The purpose of the research is to assess the role of pretreatment 18F-FDG PET/CT parameters in predicting the efficacy of 125I seed implantation in the treatment of malignant tumors, in order to allow for timely clinical interventions and adjustments in the treatment regimen. Methods A retrospective analysis was made on patients who were treated with 125I seed implantation for malignant tumors and underwent 18F-FDG PET/CT before treatment from November 2019 to November 2023 in our hospital. The clinical data of 41 patients with 69 lesions were collected completely, including age, gender, primary tumor and seed implantation sites. Metabolic parameters including TLG, MTV, SUVmax-bw, SUVmax-bsa, SUVmax-lbm, SUVmean-bw, SUVmean-bsa, SUVmean-lbm, SUVpeak-bw, SUVpeak-bsa, SUVpeak-lbm, TLR, TLMR, TBR and TBMR were measured at pretreatment PET/CT. The patients were followed up at 4 months after the procedure by CT scans. The efficacy of response was evaluated by using the response evaluation criteria in solid tumors (RECIST1.1). Results The area under the curves for TLG and MTV were 0.815 (P<0.001) and 0.804 (P<0.001) respectively. Univariate logistic regression analysis and multivariate logistic regression analysis. The results showed that only the MTV (OR: 6.477, 95%CI: 1.157-36.271, P=0.034) was an independent prognostic factor for the efficacy of 125I seed implantation for malignant tumors. Conclusion In patients with malignant tumors treated with 125I seed implantation, the 18F-FDG PET/CT parameters MTV in the prediction of the efficacy was superior to SUVmax, SUVmean and SUVpeak which normalized by body weight, body surface area and lean body mass, as well as to TLR, TLMR, TBR and TBMR. The 18F-FDG PET/CT parameter MTV was an independent prognostic factor for the efficacy of 125I seed implantation in the treatment of malignant tumors.
- Conditions
- Malignant Tumors
- Keywords
- 125I seed; Brachytherapy, Malignant tumors, PET/CT, MTV, TLG, SUV, Efficacy prediction
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 125I seed implantation treatment group | Inform the patient of relevant precautions and obtain signed informed consent. Upload CT data in DICOM format to the TPS system. Contour the tumor target volume and critical organs layer by layer. Design the needle insertion direction, angle, and depth. Determine the prescribed dose, number of implants, and activity. Obtain the Dose and Volume Histogram (DVH). For patients without prior external beam radiotherapy, the prescribed dose is 120 Gy. For those with prior external beam radiotherapy, the prescribed dose ranges from 80 to 100 Gy, ensuring surrounding critical organs receive doses within safe limits. Position, immobilize, disinfect, and drape the patient according to surgical positioning. After instructing the patient to hold their breath, perform CT scanning for localization. Following local anesthesia, complete particle implantation according to the preoperative plan. After particle implantation, perform another CT scan to verify dose distribution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor size
Referencing the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), efficacy is categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progression Disease (PD). Objective response rate (ORR) was defined as the proportion of lesions achieving CR or PR, while non-ORR was defined as the proportion of lesions achieving SD or PD.
Measured: 4 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Jan 2019
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208487
- Sponsor's protocol ID
- 2025ky281
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watanabe H, Okada M, Kaji Y, Satouchi M, Sato Y, Yamabe Y, Onaya H, Endo M, Sone M, Arai Y. [New response evaluation criteria in solid tumours-revised RECIST guideline (version 1.1)]. Gan To Kagaku Ryoho. 2009 Dec;36(13):2495-501. Japanese.
PubMed 20009446
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Pretreatment PET/CT Parameters for Predicting the Efficacy of 125I Seed Implantation in the Treatment of Malignant Tumors
- ClinicalTrials.gov ID
- NCT07208487
- Acronym / sponsor ID
- 2025ky281
- Conditions
- Malignant Tumors
- Keywords
- 125I seed; Brachytherapy, Malignant tumors, PET/CT, MTV, TLG, SUV, Efficacy prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to determine if pre-treatment 18F-FDG PET/CT metabolic parameters could predict the effectiveness of 125I seed implantation for malignant tumors. In a retrospective analysis of 41 patients with 69 lesions, various parameters were measured. The results identified Metabolic Tumor Volume (MTV) as the most significant independent prognostic factor, outperforming other standardized uptake values (SUV) and ratios. A higher MTV was associated with a worse treatment outcome, suggesting it is a valuable predictor for guiding treatment decisions.
Detailed description
Objective The purpose of the research is to assess the role of pretreatment 18F-FDG PET/CT parameters in predicting the efficacy of 125I seed implantation in the treatment of malignant tumors, in order to allow for timely clinical interventions and adjustments in the treatment regimen. Methods A retrospective analysis was made on patients who were treated with 125I seed implantation for malignant tumors and underwent 18F-FDG PET/CT before treatment from November 2019 to November 2023 in our hospital. The clinical data of 41 patients with 69 lesions were collected completely, including age, gender, primary tumor and seed implantation sites. Metabolic parameters including TLG, MTV, SUVmax-bw, SUVmax-bsa, SUVmax-lbm, SUVmean-bw, SUVmean-bsa, SUVmean-lbm, SUVpeak-bw, SUVpeak-bsa, SUVpeak-lbm, TLR, TLMR, TBR and TBMR were measured at pretreatment PET/CT. The patients were followed up at 4 months after the procedure by CT scans. The efficacy of response was evaluated by using the response evaluation criteria in solid tumors (RECIST1.1). Results The area under the curves for TLG and MTV were 0.815 (P<0.001) and 0.804 (P<0.001) respectively. Univariate logistic regression analysis and multivariate logistic regression analysis. The results showed that only the MTV (OR: 6.477, 95%CI: 1.157-36.271, P=0.034) was an independent prognostic factor for the efficacy of 125I seed implantation for malignant tumors. Conclusion In patients with malignant tumors treated with 125I seed implantation, the 18F-FDG PET/CT parameters MTV in the prediction of the efficacy was superior to SUVmax, SUVmean and SUVpeak which normalized by body weight, body surface area and lean body mass, as well as to TLR, TLMR, TBR and TBMR. The 18F-FDG PET/CT parameter MTV was an independent prognostic factor for the efficacy of 125I seed implantation in the treatment of malignant tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 125I seed implantation treatment group | – | –Inform the patient of relevant precautions and obtain signed informed consent. Upload CT data in DICOM format to the TPS system. Contour the tumor target volume and critical organs layer by layer. Design the needle insertion direction, angle, and depth. Determine the prescribed dose, number of implants, and activity. Obtain the Dose and Volume Histogram (DVH). For patients without prior external beam radiotherapy, the prescribed dose is 120 Gy. For those with prior external beam radiotherapy, the prescribed dose ranges from 80 to 100 Gy, ensuring surrounding critical organs receive doses within safe limits. Position, immobilize, disinfect, and drape the patient according to surgical positioning. After instructing the patient to hold their breath, perform CT scanning for localization. Following local anesthesia, complete particle implantation according to the preoperative plan. After particle implantation, perform another CT scan to verify dose distribution. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with malignant tumors who underwent 125I seed implantation therapy at the Department of Nuclear Medicine, Jiangxi Cancer Hospital between November 2019 and November 2023 and received preoperative 18F-FDG PET/CT scans.
Key inclusion criteria (1 listed)
- Interval between PET/CT imaging and 125I seed implantation ≤4 weeks; (2)CT follow-up performed 4 months post-125I seed implantation; (3) Primary tumor pathologically or cytologically diagnosed as malignant; (4) Metastatic or recurrent lesions implanted with 125I confirmed by cytological aspiration or imaging
Key exclusion criteria (1 listed)
- Lesions too small or SUVmax < 2.5, rendering them unidentifiable by software for PET/CT parameter measurement; (2) Two 125I seed implantation procedures performed within 6 months for the same lesion; (3) Incomplete clinical or imaging data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor size
Time frame: 4 months post-surgery
Referencing the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), efficacy is categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progression Disease (PD). Objective response rate (ORR) was defined as the proportion of lesions achieving CR or PR, while non-ORR was defined as the proportion of lesions achieving SD or PD.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Results publication: PubMed 20009446Watanabe H, Okada M, Kaji Y, Satouchi M, Sato Y, Yamabe Y, Onaya H, Endo M, Sone M, Arai Y. [New response evaluation criteria in solid tumours-revised RECIST guideline (version 1.1)]. Gan To Kagaku Ryoho. 2009 Dec;36(13):2495-501. Japanese.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumors, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor size (time frame: 4 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07208487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.