Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193752
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2005-09-13
Brief Title:
Para-Aortic Lymph Nodal Staging Evaluation of Treatment Outcome by 18F FDG-PET in Advanced Cancer Cervix
Sponsor:
Tata Memorial Hospital
Organization:
Tata Memorial Hospital
Study Overview
Official Title:
Para-Aortic Lymph Nodal Staging and Evaluation of Treatment Outcome by 18F-fluorodeoxyglucose Positron Emission Tomography FDG-PET in Advanced Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
18F-fluorodeoxyglucose Positron Emission Tomography FDG-PET Imaging has been extensively used in the evaluation of various malignancies and is rapidly being recognized as a mandatory investigations 18F-fluorodeoxyglucose Positron Emission Tomography FDG-PET Imaging has also been tried in cervical cancers with excellent results for detection of both pelvic and extra-pelvic disease in terms of sensitivity and specificity Till date PET Imaging has been reported to have highest sensitivity and specificity for detection of disease and treatment failures compared to other non-invasive investigations available Treatment decisions Localized RT Vs Extended RT will be according to the results of PET Scans The treatment response outcome and follow-up will be labelled according to the PET Scan results and will be directed for treatment accordingly
Detailed Description:
BACKGROUND AND RATIONALE
Carcinoma Cervix is the commonest malignancy and a leading cause of cancer mortality seen in Indian women At Tata Memorial Hospital Carcinoma Cervix constitutes approximately 10 of all cancers 1 Nearly 85 of the patients present with advanced stages FIGO Stage IIIII The main stay of treatment has traditionally been radical radiation therapy with 80-90 of patients requiring radiation in their lifetime and over decades the survival rates have achieved a plateau of 30 - 55 at 5 years In patients with advanced stages stages IIB to IVA 15 - 38 have para-aortic lymph nodal metastases 2 Identification of para-aortic nodal status allows modification of radiation therapy fields to include this nodal disease which because of intestinal morbidity is not routinely included in the treatment field by most of the Radiation Oncologists Extended field radiation therapy that includes the para-aortic nodes is associated with a 31 to 50 5 year-survival depending on the location and extent of para-aortic nodal metastasis and the likelihood of controlling the pelvic disease 3-5 Therefore in advanced cervical cancer it has been reported that progression-free survival is significantly related to para-aortic lymph node metastasis 6-8 In a collective series of Gynecologic Oncology Group protocols Para aortic nodal status was the most significant indication of recurrence 6
A number of noninvasive modalities have been used to evaluate the status of para-aortic nodal metastasis The introduction of Computed Tomographic CT Scanning in the mid-1970s provided a method of para-aortic nodal disease evaluation 9 CT Scanning has been widely used for clinical staging but its sensitivity for nodal metastasis is only 44 10 In contrast to CT which primarily relies on the morphologic criteria FDG-PET can non-invasively assess metabolic activity in cancers and metastatic lesions The differentiation capability for malignant lesions of FDG-PET is not compromised by using morphologic size criteria Even malignant lesions less than 1 cm in diameter that manifest high FDG uptake can be differentiated from nonmalignant tissue by using PET Therefore FDG-PET can detect metastatic para-aortic lymph nodes in patients with advanced cervical cancer whose lymph nodes have not been abnormally enlarged
Many published data have previously reported the clinical value of 18F FDG PET for imaging the primary tumor staging the nodal and visceral involvement and also detecting a recurrent disease 11-19 Rose et al 11 used FDG-PET for evaluating nodal metastasis in locally advanced cervical cancer before surgical staging with a sensitivity of 75 and a specificity of 92 to detect the metastases of para-aortic lymph nodes They found that the accuracy of FDG-PET was greater than that of CT in detecting the para-aortic lymph nodal metastasis In a similar series Wu et al have reported a sensitivity of 857 a specificity of 944 and an accuracy of 92 with FDG PET to detect para-aortic lymph nodal metastasis in patients with advanced cervical cancer and negative abdominal CT findings Grigsby et al 12 demonstrated that FDG-PET detects more abnormal lymph node regions than does CT and that FDG-PET findings are a better predictor of survival than those of CT in patients with cervical cancer
Magnetic Resonance Imaging MRI has also been reviewed in evaluating both the primary disease at cervix and also para-aortic nodal staging MRI has been recognized as an important imaging modality for the management of cervical cancer because of its multiplanar capability distinct tissue contrast characteristics using various pulse sequences and excellent tissue contrast particularly between tumor and surrounding normal tissues However PET findings were most often compared to CT results while MRI is nowadays considered as the modality of choice for staging the primary tumor 2021 Only one study by Narayan et al has compared the respective value of MRI and PET for staging loco-regionally advanced cervical cancer 22 Their study found that the primary tumor was similarly detected by the two imaging techniques with a sensitivity of 100 On the other hand except for small-volume metastases PET had a sufficiently high positive predictive value 91 in the pelvis and para-aortic region to obviate lymph node sampling More recent studies have shown that the 3D quantitative imaging-based method of tumor size assessment using MRI is highly accurate in determining actual tumor size and extent 23-27 and may be superior to clinical palpation in predicting local tumor control 232528 Conversely MRI accuracy was insufficient for nodal management If MRI remains the modality of choice for evaluating the loco-regional status of the primary tumor metabolic imaging ie FDG PET seems particularly useful for staging in one session extra pelvic nodal metastases Thus PET may have a significant impact on treatment decision-making
Identification of para-aortic nodal status allows modification of radiation therapy fields to include this nodal disease Stehman et al previously demonstrated the prognostic importance of para-aortic nodal status in locally advanced cervical carcinoma 6 In advanced cervical cancer it has been reported that progression-free survival is significantly related to para-aortic lymph node metastasis 6-8 Recent studies have shown a survival benefit in patients with positive para-aortic nodes treated by extended-field irradiation and concurrent radio-sensitizing chemotherapy 29-31
PET is also of great value for optimally confirming a complete remission and detecting a recurrence non-invasively in post-treatment follow-up More recently positron emission tomography PET with the glucose analogue 18 F-fluorodeoxyglucose FDG has demonstrated promising results in evaluating tumor response and predicting survival after primary treatment with radiation therapy or chemotherapy for several tumor types including head-and-neck cancer breast cancer seminoma colorectal cancer lymphoma and lung cancer 33-40 Recently Grigsby et al have reported the role of FDG PET in posttherapy surveillance monitoring in a series of 75 patients with cervical cancer They have concluded that FDG-PET is a valuable tool to evaluate the response of both at primary and its lymph node disease after radiation therapy and chemotherapy and for the Post-Rx surveillance of patients to detect asymptomatic recurrence 41
Carcinoma Cervix is the commonest malignancy and a leading cause of cancer mortality seen in Indian women At Tata Memorial Hospital Carcinoma Cervix constitutes approximately 10 of all cancers 1 Nearly 85 of the patients present with advanced stages FIGO Stage IIIII The main stay of treatment has traditionally been radical radiation therapy with 80-90 of patients requiring radiation in their lifetime and over decades the survival rates have achieved a plateau of 30 - 55 at 5 years In patients with advanced stages stages IIB to IVA 15 - 38 have para-aortic lymph nodal metastases 2 Identification of para-aortic nodal status allows modification of radiation therapy fields to include this nodal disease which because of intestinal morbidity is not routinely included in the treatment field by most of the Radiation Oncologists Extended field radiation therapy that includes the para-aortic nodes is associated with a 31 to 50 5 year-survival depending on the location and extent of para-aortic nodal metastasis and the likelihood of controlling the pelvic disease 3-5 Therefore in advanced cervical cancer it has been reported that progression-free survival is significantly related to para-aortic lymph node metastasis 6-8 In a collective series of Gynecologic Oncology Group protocols Para aortic nodal status was the most significant indication of recurrence 6
A number of noninvasive modalities have been used to evaluate the status of para-aortic nodal metastasis The introduction of Computed Tomographic CT Scanning in the mid-1970s provided a method of para-aortic nodal disease evaluation 9 CT Scanning has been widely used for clinical staging but its sensitivity for nodal metastasis is only 44 10 In contrast to CT which primarily relies on the morphologic criteria FDG-PET can non-invasively assess metabolic activity in cancers and metastatic lesions The differentiation capability for malignant lesions of FDG-PET is not compromised by using morphologic size criteria Even malignant lesions less than 1 cm in diameter that manifest high FDG uptake can be differentiated from nonmalignant tissue by using PET Therefore FDG-PET can detect metastatic para-aortic lymph nodes in patients with advanced cervical cancer whose lymph nodes have not been abnormally enlarged
Many published data have previously reported the clinical value of 18F FDG PET for imaging the primary tumor staging the nodal and visceral involvement and also detecting a recurrent disease 11-19 Rose et al 11 used FDG-PET for evaluating nodal metastasis in locally advanced cervical cancer before surgical staging with a sensitivity of 75 and a specificity of 92 to detect the metastases of para-aortic lymph nodes They found that the accuracy of FDG-PET was greater than that of CT in detecting the para-aortic lymph nodal metastasis In a similar series Wu et al have reported a sensitivity of 857 a specificity of 944 and an accuracy of 92 with FDG PET to detect para-aortic lymph nodal metastasis in patients with advanced cervical cancer and negative abdominal CT findings Grigsby et al 12 demonstrated that FDG-PET detects more abnormal lymph node regions than does CT and that FDG-PET findings are a better predictor of survival than those of CT in patients with cervical cancer
Magnetic Resonance Imaging MRI has also been reviewed in evaluating both the primary disease at cervix and also para-aortic nodal staging MRI has been recognized as an important imaging modality for the management of cervical cancer because of its multiplanar capability distinct tissue contrast characteristics using various pulse sequences and excellent tissue contrast particularly between tumor and surrounding normal tissues However PET findings were most often compared to CT results while MRI is nowadays considered as the modality of choice for staging the primary tumor 2021 Only one study by Narayan et al has compared the respective value of MRI and PET for staging loco-regionally advanced cervical cancer 22 Their study found that the primary tumor was similarly detected by the two imaging techniques with a sensitivity of 100 On the other hand except for small-volume metastases PET had a sufficiently high positive predictive value 91 in the pelvis and para-aortic region to obviate lymph node sampling More recent studies have shown that the 3D quantitative imaging-based method of tumor size assessment using MRI is highly accurate in determining actual tumor size and extent 23-27 and may be superior to clinical palpation in predicting local tumor control 232528 Conversely MRI accuracy was insufficient for nodal management If MRI remains the modality of choice for evaluating the loco-regional status of the primary tumor metabolic imaging ie FDG PET seems particularly useful for staging in one session extra pelvic nodal metastases Thus PET may have a significant impact on treatment decision-making
Identification of para-aortic nodal status allows modification of radiation therapy fields to include this nodal disease Stehman et al previously demonstrated the prognostic importance of para-aortic nodal status in locally advanced cervical carcinoma 6 In advanced cervical cancer it has been reported that progression-free survival is significantly related to para-aortic lymph node metastasis 6-8 Recent studies have shown a survival benefit in patients with positive para-aortic nodes treated by extended-field irradiation and concurrent radio-sensitizing chemotherapy 29-31
PET is also of great value for optimally confirming a complete remission and detecting a recurrence non-invasively in post-treatment follow-up More recently positron emission tomography PET with the glucose analogue 18 F-fluorodeoxyglucose FDG has demonstrated promising results in evaluating tumor response and predicting survival after primary treatment with radiation therapy or chemotherapy for several tumor types including head-and-neck cancer breast cancer seminoma colorectal cancer lymphoma and lung cancer 33-40 Recently Grigsby et al have reported the role of FDG PET in posttherapy surveillance monitoring in a series of 75 patients with cervical cancer They have concluded that FDG-PET is a valuable tool to evaluate the response of both at primary and its lymph node disease after radiation therapy and chemotherapy and for the Post-Rx surveillance of patients to detect asymptomatic recurrence 41
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None