| CTRI Number |
CTRI/2023/03/050433 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
PET IN OVARIAN CARCINOMA: AN IAEA INTERNATIONAL COOPERATIVE STUDY |
|
Scientific Title of Study
|
PET IN OVARIAN CARCINOMA (POCA): AN IAEA INTERNATIONAL COOPERATIVE STUDY (E.1.30.50) |
| Trial Acronym |
POCA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harmandeep Singh |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
Department of Nuclear Medicine, PGIMER, Sector-12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
|
| Fax |
|
| Email |
drharmandeepsingh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Harmandeep Singh |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
Department of Nuclear Medicine, PGIMER, Sector-12, Chandigarh
CHANDIGARH 160012 India |
| Phone |
|
| Fax |
|
| Email |
drharmandeepsingh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Harmandeep Singh |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
Department of Nuclear Medicine, PGIMER, Sector-12, Chandigarh
CHANDIGARH 160012 India |
| Phone |
|
| Fax |
|
| Email |
drharmandeepsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Atomic Energy Agency (IAEA), Vienna International Centre,
PO Box 100, 1400
Vienna, Austria. |
|
|
Primary Sponsor
|
| Name |
International Atomic Energy Agency (IAEA) |
| Address |
Vienna International Centre, PO Box 100, 1400 Vienna, Austria. |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harmandeep Singh |
PGIMER |
PET center, Department of Nuclear Medicine, Nehru Hospital, Sector-12, Chandigarh-160012 Chandigarh CHANDIGARH |
7087003374
drharmandeepsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria:
1. Patients with histologically proven diagnosis of ovarian carcinoma
2. Peritoneal carcinomatosis known or with high suspicion, without known further metastatic spread, before undergoing debulking surgery
3. 18F-FDG PET/CT performed prior to surgery less than 4 weeks
4. Signature of informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Metastatic disease known apart from peritoneal carcinomatosis
2. Diabetic patients with bad control
3. Debulking surgery not indicated
4. Surgical contraindications
5. Unable to consent
6. Estimated glomerular filtration rate (eGFR) < 30
7. Claustrophobia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the diagnostic performance of 18F-FDG PET/CT and its comparison to conventional imaging for staging OC. |
Within 4 weeks before surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes include the assessment of prognostic value of different peritoneal carcinomatosis scoring systems and comparison with 18F-FDG PET/CT in ovarian cancer patients.
Performance of different PET systems and inter reader agreement (using cohen’s kappa) will also be assessed. |
Post surgery follow up |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ovarian carcinomas (OC) are rarely diagnosed in the early stage, without peritoneal spread (<5% of cases) while more than 90% presents with spread to the peritoneum and beyond. Common metastatic sites include liver, lung, spleen, transmural involvement of intestine, and skeletal metastases as well as involvement of the inguinal, supraclavicular, and axillary nodes. Cytoreductive surgery and chemotherapy are standard of care treatment in OC. Laparotomy and conventional imaging play important role in the precise assessment of tumour extent (primary tumour and peritoneal sites, regional lymph nodes, and distant sites) and deciding for primary surgery or neoadjuvant treatment. However, several anatomic locations such as retro-hepatic areas, retroperitoneal spaces, porta hepatis, are difficult to explore and up to 30% of patients are understaged at laparotomy, due to unexpected peritoneal or extra-abdominal (nodal or extranodal) spread. Therefore, accurate presurgical staging is essential. Contrast-enhanced CT (ceCT) is useful to detect peritoneal spread of tumour and metastatic lesions, but despite being considered the modality of choice, its accuracy in staging OC ranges from 53% to 92%. with limited ability to detect small cancer implants on bowel surfaces, mesentery and parietal peritoneum. MR imaging demonstrates advantages relative to ceCT in evaluating metastatic spread in OC due to its higher soft tissue contrast and lack of radiation exposure. On MRI, lesions may be obscured by spleen or distortion artifacts. Moreover, MR imaging does not overcome the problem of diagnosing lymph nodal and peritoneal sites of malignancy by size criteria. Currently, MR imaging could be considered a second-line technique, in patients with contraindications to ceCT and/or in patients with inconclusive ceCT findings. Nearly 40% of relapses following primary treatment of epithelial ovarian cancer with surgery and chemotherapy for stage 3 disease ( Nearly 70% of cases at presentation ) are extra abdominal which will be missed by conventional radiological procedures like CT and MRI abdomen. There is a need for imaging modalities with better diagnostic accuracy in staging OC. Glucose transporter 1 (GLUT-1) over-expression and microvessel density/tumour proliferation lead to high 18F-FDG uptake in OC. There is a high chance of picking them up early in primary and relapse setting using PET which can modify the mode and intensity of treatment and improve survivals. Thereby, 18F- FDG PET/CT may overcome limitations of conventional imaging in the preoperative staging of OC  patients. Various studies have evaluated the role of 18F-FDG PET/CT in evaluation of suspected OC, staging and most important, in biochemical recurrence proving its advantage over ceCT. 18F- FDG PET/CT has better diagnostic performance compared with conventional imaging for the evaluation of the lymph node involvement (even sub-cm nodes), extra-abdominal spread, and detection of unsuspected extra abdominal spread and other malignant tumours being a whole body technique, leading to upstaging of disease in a significant percentage of patients and alter therapeutic decision making. A study showed that the sensitivity of 18F-FDG PET and ceCT is not the same in the different portions of the abdominopelvic cavity. However, literature is still limited and 18F-FDG PET is not routinely used in staging OC. The present study aims to compare 18F- FDG PET/CT and ceCT in the presurgical evaluation of peritoneal carcinomatosis in ovarian cancer patients.
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