| Primary | Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy | A positive malignant residual mass was defined as focal 18F- Fluorothymidine (FLT) uptake within the residual mass greater than the normal mediastinal background uptake. FLT uptake within the mass lower than the mediastinal was considered non-malignant. The positive/negative FLT uptake was correlated with biopsy results within the residual mass (presence or absence of malignant tumor cells). | 21/22 participants were analyzed because one participant was not treated ineligible per CT criteria. Data was collected for only the Arm/Group of participants with residual masses. | Posted | | Count of Participants | | Participants | | Up to 3.5 years | | | | ID | Title | Description |
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| OG000 | Participants Scanned in the Evaluation of Residual Masses After Therapy | Patients undergo a 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected](streamdown:incomplete-link) |
| | | Title | Denominators | Categories |
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| Presence of FLT uptake | | | | Absence of FLT uptake and FLT uptake lower than normal mediastinum | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Wilcoxon signed-rank test | | <0.001 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | 18F- Fluorothymidine (FLT) Uptake Within the Tumor(s) Between Baseline vs Completion of Therapy Scans | FLT uptake within the tumor(s) using standard uptake value (SUVmax) was compared between baseline and completion of therapy scans. | 8/9 participants were analyzed at baseline because the FLT dose failed synthesis in 1 participant. 6/9 participants were analyzed at completion of therapy because 1 participant refused to be imaged, 1 participant missed scan appointment, and 1 patient's FLT dose failed synthesis at baseline and was not scanned at completion of therapy either The rows at baseline and completion of therapy represent the pts: 8 patients were scanned at baseline and 6 pts were scanned at completion of therapy. | Posted | | Mean | Standard Deviation | SUVmax | | up to 4.5 years | | | | ID | Title | Description |
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| OG000 | Participants Scanned at Baseline & After Chemotherapy | Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B. Fluordeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans](streamdown:incomplete-link) |
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| Secondary | Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline Scan and SUVmax After Completion Scan in Responders and Non-responders' Patients | The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after completion of therapy. | 8/9 participants were analyzed at baseline and 6/9 were analyzed after completion of therapy because 6 patients completed the 3 scans (baseline, at 2-cycles and after completion of therapy). This outcome measure data is collected only for one of the Arm/Group. The other group of participants were not scanned at baseline and after treatment. This data is for baseline (8 patients) and after therapy (6 patients). The outcome measure refers to baseline and after completion of therapy. | Posted | | Median | Standard Deviation | Standard Uptake Value (SUV) - units | | up to 4.5 years | | | | ID | Title | Description |
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| OG000 | Participants Scanned at Baseline & After Chemotherapy | Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans](streamdown:incomplete-link) |
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| Secondary | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | The maximum standard uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). | 6/9 participants were analyzed after completion of therapy because the FLT dose failed synthesis in 1 participant at baseline and was not scanned at completion, 1 participant refused to be imaged and 1 participant missed scan appointment. The other group of participants were not scanned at baseline and after treatment. | Posted | | Mean | Standard Deviation | SUV | | Up to 4.5 years | | | | ID | Title | Description |
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| OG000 | Participants Scanned at Baseline | Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline. Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans](streamdown:incomplete-link) | | OG001 | Participants Scanned After Completion of Therapy | Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans](streamdown:incomplete-link) |
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| Secondary | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | After 1 hour post-injection of fluorodeoxyglucose (FDG), the maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated was calculated within the residual mass. The ratio between SUVmax within the residual mass and SUVmean in the pool blood was measured. | 21/22 participants were analyzed because one participant was not treated ineligible per CT criteria. Data collected only from residual mass Group of patients for this Outcome Measure. | Posted | | Number | | SUVmax/Tumor blood ratio | | up to 3.5 years | | | | ID | Title | Description |
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| OG000 | Participants Scanned in the Evaluation of Residual Masses After Therapy | Patients undergo a 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected](streamdown:incomplete-link) |
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| Secondary | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | The maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated within the residual mass at 1 h and at 2 hours post-injection of FLT. | This outcome measure was collected for Arm/Group of patients with residual tumor masses after therapy. 21/22 participants were analyzed in thisArm/Group because one participant was not scanned with FLT, ineligible per CT criteria. 18/21 were analyzed in the second Arm/Group because no scans were available for three participants at 2 hours post injection. | Posted | | Mean | Standard Deviation | SUV | | up to 3.5 years | | | | ID | Title | Description |
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| OG000 | Participants Scanned in the Evaluation of Residual Masses After Therapy at 1 Hour Post Injection | Participants with residual masses after therapy were evaluated with FLT-positron-emission tomography (PET)/computed tomography (CT), acquiring the images after 1 hour after the intravenous injection of FLT to evaluate the tumor uptake value at 1 hour post injection. | | OG001 | Participants Scanned in the Evaluation of Residual Masses After Therapy at 2 Hours Post Injection | Participants with residual masses after therapy were evaluated with FLT-positron-emission tomography (PET)/computed tomography (CT), acquiring the images after 2 hours of the intravenous injection of FLT to evaluate the tumor uptake at at 2 hours post injection. |
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| Secondary | Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline and at Mid-treatment (Post-2 Cycles) Scan | The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after 2-cycles of therapy. | 8/9 participants were analyzed because the FLT dose failed synthesis in 1 participant, 1 participant refused to be imaged. | Posted | | Mean | Standard Deviation | SUVmax | | Up to 4.5 years | | | | ID | Title | Description |
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| OG000 | Participants Scanned at Baseline, at 2 Cycles & After ChemotherapyChemotherapy | Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans](streamdown:incomplete-link) |
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| Secondary | Time to Progression | The time to progression (defined as time in months from 3'-deoxy-3'-[18F] fluorothymidine (FLT)-scan until patient progressed) was compared between the two groups (patients with higher Maximum Standard Uptake Value (SUVmax) vs lower SUVmax, using the median SUV value). | 3/6 participants were analyzed because 3 did not progress while on study. Data collected only from the Group of patients scanned at baseline and after chemotherapy for this Outcome Measure. | Posted | | Mean | Standard Deviation | Months | | up to 4.5 years | | | | ID | Title | Description |
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| OG000 | Participants Scanned After Chemotherapy | Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B. Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans](streamdown:incomplete-link) |
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| Secondary | 18F- Fluorothymidine (FLT) Uptake, Positron-emission Tomography (PET) Standard Uptake Value (SUV)Max in Malignant Residual Tumors Versus Benign Lesions After Therapy | FLT uptake was calculated within malignant residual tumors versus benign lesions using maximum standard uptake value (SUVmax). | | Posted | | Mean | Standard Deviation | SUVmax | | up to 4.5 years | | | | ID | Title | Description |
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| OG000 | Participants Scanned in the Evaluation of Residual Masses After Therapy | Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated. Biopsy: Biopsy taken [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected](streamdown:incomplete-link) |
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| Other Pre-specified | Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | 8/9 patients were injected with the tracer (FLT) and scanned in the first Arm/Group, and 21/22 in the second Arm/Group. | Posted | | Count of Participants | | Participants | | Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days. | | | | ID | Title | Description |
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| OG000 | Participants Scanned at Baseline & After Chemotherapy | Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B. Fluorodeoxyglucose F 18: Undergo scans [3'-deoxy-3'-[F-18] fluorothymidine: Undergo scans computed tomography: Undergo scans](streamdown:incomplete-link) | | OG001 |
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