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We hypothesize that 18FDG Positron Emission Tomography (FDG PET) imaging, carried out after the first cycle of chemotherapy, will identify responders, thus permitting early termination of potential toxic therapy in non- responders leading to a significant decrease in morbidity and cost. The value of PET imaging as an early predictor of response to chemotherapy has been shown in other cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | The study will evaluate the potential of PET imaging to identify early responders to chemotherapy. Patients entered into this study will undergo FDG PET within 2 weeks prior to chemotherapy and prior to initiation of the second course of chemotherapy. All images will be carried out in the same manner with respect to equipment, acquisition parameters, and time post injection, to ensure that changes in standard uptake value(SUV) correlate with metabolic changes. This will be correlated with response determined by changes in serum CA 125 levels. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1: FDG PET | Procedure | The study will evaluate the potential of PET imaging to identify early responders to chemotherapy. Patients entered into this study will undergo FDG PET within 2 weeks prior to chemotherapy and prior to initiation of the second course of chemotherapy. All images will be carried out in the same manner with respect to equipment, acquisition parameters, and time post injection, to ensure that changes in standard uptake value(SUV) correlate with metabolic changes. This will be correlated with response determined by changes in serum CA 125 levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Partial metabolic response (PMR) - A reduction of a minimum of 15-25% in tumour 18FDG SUV after one cycle of chemotherapy, and greater than 25% after more than one treatment cycle. | Conclusion of the study | |
| Partial metabolic response (PMR) - A reduction of a minimum of 15-25% in tumour 18FDG SUV after one cycle of chemotherapy, and greater than 25% after more than one treatment cycle. | Completion of study | |
| Complete metabolic response (CMR) - Complete resolution of 18FDG uptake within the tumour volume so that it was indistinguishable from surrounding normal tissue. | completion of study | |
| Progressive metabolic disease- increase in 18FDG tumour SUV of greater than 25% within tumour region defined on the baseline scan, visible increase in the extent of 18FDG tumour uptake (>20% in the longest dimension). | completion of study | |
| Stable metabolic disease (SMD) -An increase in tumour 18FDG SUV of less than 25% or a decrease of less than 15% and no visible increase in extent of 18FDG uptake in tumor (>20% in the longest dimension). | completion of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neeta Pandit-Taskar, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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