Cervical CancerPhase 2NCT00199680
Interest of PET Imagery With 18-FDG in the Extension Assessment of the Cervical Cancer
A Phase 2 study testing PET in people with Cervical Cancer, run by University Hospital, Limoges at 3 sites in France.
Trial summary
In cervical cancer prognosis factors are size of the tumour, pelvic and para-aortic lymph nodes involvement. The initial treatment taking is determined by lymph node evaluation. Early stage cervical cancers at their very beginning, with no lymph node involvement, will be treated either by surgery only or by… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- PET
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2003to not given
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with cervical carcinoma: histological proof of epidermoid carcinoma or of adenocarcinoma
- Stage I to IV (limited to pelvic) (FIGO Classification) (see appendix 3)
- Age ≥ 18 years old
- No contra-indication to surgery
- Dated, informed and signed consent from the patient
Who cannot join
- Metastatic cervical cancer with extra-pelvic metastasis
- Contra-indication to MRI: implantation of an electronic device, metallic or ferromagnetic foreign body
- Serious co-existing affection with vital prognosis
- Diabetes uncontrolled by a classical treatment: glycaemia > 1.4g/l
- Pregnancy and lactation
- Uncontrolled infection
- Other cancer within the previous 5 years, except skin basal cell carcinoma, or in situ cervical cancer
- Patient with some deficiency preventing her from completely understanding any requirement of the study, which might compromise the patient's consent and/or the observance of the protocol and the consistent participation to the study.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Gynécologie Obstétrique
Limoges, 87000
Yves AUBARD, MD
Yves AUBARD, MD
- Recruiting
Médecine Nucléaire
Limoges, 87000
Jacques MONTEIL, MD
Jacques MONTEIL, MD
- Recruiting
Oncologie Médicale
Limoges, 87000
Dominique GENET, MD
Dominique GENET, MD
About this study
In cervical cancer prognosis factors are size of the tumour, pelvic and para-aortic lymph nodes involvement. The initial treatment taking is determined by lymph node evaluation.
Early stage cervical cancers at their very beginning, with no lymph node involvement, will be treated either by surgery only or by radiotherapy only, or by both at the same time. At advanced stages, from proximal IB to IIB with bad prognosis (tumour larger than 4 cm and pelvic lymph node involvement), as well as for cancers up to distal stages IIB, III and IVA, treatment relies on radio-chemotherapy, either alone or pre-surgery.
Read more
The pre-therapeutic complete examination of the cervical cancer includes a clinical examination and a pelvic MRI in order to look for pelvic and para-aortic lymph nodes and to precise the volume and the spreading of the tumour in the pelvic area.
A meta-analysis estimating the interest of the MRI showed a variable sensitivity and a specificity for the detection of such lymph node metastasis with a sensitivity varying from 24 to 75 % and a specificity between 84 and 100 % according to the studies.
As for the use of an 18-FDG PET scan to detect lymph node involvement, the studies realized so far are performed, usually, on a small number of subjects and with heterogeneous populations. However, it seems that such an examination enables a better detection of lymph nodes than the MRI does, especially for para-aortic lymph nodes depending on the studies, sensitivity varies from 57 to 100 %, and specificity between 92 and 100 %.
We propose a prospective, multicentric and multidisciplinary study for the estimation of diagnosis methods. The main aim is to estimate the interest of the 18-FDG PET scan for the detection of pelvic and para-aortic lymph node metastasis in patients with cervical cancer, in comparison with the MRI. This study should enable to include 380 patients within 3 years. An 18-FDG scintigraphy will be performed before any treatment together with an MRI. A comparison between the sensitivity and the specificity of both examinations will be established and a correlation with the histology of the lymph node dissection will be made.
- Conditions
- Cervical Cancer
- Being tested
- PET
- Keywords
- PETscan, cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the pelvic and/or para-aortic lymph node involvement with the PET, in comparison with the MRI and the histological results of node dissection.
Secondary outcomes (11)
Before initial treatment
- Evaluation of the size and local spreading of the tumour with MRI.
- Evaluation of tumour fixation with PET (including SUV quantifying).
- Comparison between both imaging methods.
Post radio-chemotherapy evaluation
- Evaluation of residual tumour and/or lymph nodes by MRI in comparison with initial size.
- Evaluation of residual tumour and/or lymph node by PET with SUV quantifying and in comparison with the initial value.
- Correlation between the results obtained with imaging and the histology of the surgical resection.
Study of disease free survival.
- In advanced stages: according to pelvic and/or extra-pelvic hyperfixation with the initial PET (SUV quantifying)
- According to staging obtained by MRI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2003
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 Cervical CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Investigators
- Dominique GENET, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199680
- Sponsor's protocol ID
- I03017
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 1 Feb 2006
- Results posted
- No
Publications
Monteil J, Maubon A, Leobon S, Roux S, Marin B, Renaudie J, Genet D, Fermeaux V, Aubard Y, Tubiana-Mathieu N. Lymph node assessment with (18)F-FDG-PET and MRI in uterine cervical cancer. Anticancer Res. 2011 Nov;31(11):3865-71.
PubMed 22110211
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of PET Imagery With 18-FDG in the Extension Assessment of the Cervical Cancer
- ClinicalTrials.gov ID
- NCT00199680
- Acronym / sponsor ID
- I03017
- Conditions
- Cervical Cancer
- Keywords
- PETscan, cervical cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Oct 2003
- First posted
- 20 Sep 2005 (estimated)
- 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.
In cervical cancer prognosis factors are size of the tumour, pelvic and para-aortic lymph nodes involvement. The initial treatment taking is determined by lymph node evaluation.
Early stage cervical cancers at their very beginning, with no lymph node involvement, will be treated either by surgery only or by radiotherapy only, or by both at the same time. At advanced stages, from proximal IB to IIB with bad prognosis (tumour larger than 4 cm and pelvic lymph node involvement), as well as for cancers up to distal stages IIB, III and IVA, treatment relies on radio-chemotherapy, either alone or pre-surgery.
The pre-therapeutic complete examination of the cervical cancer includes a clinical examination and a pelvic MRI in order to look for pelvic and para-aortic lymph nodes and to precise the volume and the spreading of the tumour in the pelvic area.
A meta-analysis estimating the interest of the MRI showed a variable sensitivity and a specificity for the detection of such lymph node metastasis with a sensitivity varying from 24 to 75 % and a specificity between 84 and 100 % according to the studies.
As for the use of an 18-FDG PET scan to detect lymph node involvement, the studies realized so far are performed, usually, on a small number of subjects and with heterogeneous populations. However, it seems that such an examination enables a better detection of lymph nodes than the MRI does, especially for para-aortic lymph nodes depending on the studies, sensitivity varies from 57 to 100 %, and specificity between 92 and 100 %.
We propose a prospective, multicentric and multidisciplinary study for the estimation of diagnosis methods. The main aim is to estimate the interest of the 18-FDG PET scan for the detection of pelvic and para-aortic lymph node metastasis in patients with cervical cancer, in comparison with the MRI. This study should enable to include 380 patients within 3 years. An 18-FDG scintigraphy will be performed before any treatment together with an MRI. A comparison between the sensitivity and the specificity of both examinations will be established and a correlation with the histology of the lymph node dissection will be made.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with cervical carcinoma: histological proof of epidermoid carcinoma or of adenocarcinoma
- Stage I to IV (limited to pelvic) (FIGO Classification) (see appendix 3)
- Age ≥ 18 years old
- No contra-indication to surgery
- Dated, informed and signed consent from the patient
Key exclusion criteria (8 listed)
- Metastatic cervical cancer with extra-pelvic metastasis
- Contra-indication to MRI: implantation of an electronic device, metallic or ferromagnetic foreign body
- Serious co-existing affection with vital prognosis
- Diabetes uncontrolled by a classical treatment: glycaemia > 1.4g/l
- Pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET | Procedure or surgery | – |
Primary outcome
Estimation of the pelvic and/or para-aortic lymph node involvement with the PET, in comparison with the MRI and the histological results of node dissection.
11 secondary outcomes
Before initial treatment
- Evaluation of the size and local spreading of the tumour with MRI.
- Evaluation of tumour fixation with PET (including SUV quantifying).
- Comparison between both imaging methods.
Post radio-chemotherapy evaluation
- Evaluation of residual tumour and/or lymph nodes by MRI in comparison with initial size.
- Evaluation of residual tumour and/or lymph node by PET with SUV quantifying and in comparison with the initial value.
- Correlation between the results obtained with imaging and the histology of the surgical resection.
Study of disease free survival.
- In advanced stages: according to pelvic and/or extra-pelvic hyperfixation with the initial PET (SUV quantifying)
- According to staging obtained by MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2006.
- Derived from this study: PubMed 22110211Monteil J, Maubon A, Leobon S, Roux S, Marin B, Renaudie J, Genet D, Fermeaux V, Aubard Y, Tubiana-Mathieu N. Lymph node assessment with (18)F-FDG-PET and MRI in uterine cervical cancer. Anticancer Res. 2011 Nov;31(11):3865-71.
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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.
Dominique GENET, MD principal investigator
University Hospital, Limoges
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET in people with Cervical Cancer, run by University Hospital, Limoges at 3 sites in France.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENET, MD (+33(0) 555 056 396, dominique.genet@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the pelvic and/or para-aortic lymph node involvement with the PET, in comparison with the MRI and the histological results of node dissection.. 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 NCT00199680, 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 1 Feb 2006.