A Prospective Study Comparing Three Injection Sites to Detect Sentinel Lymph Nodes in Endometrial Cancer

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Brief Title

A Prospective Study Comparing Three Injection Sites to Detect Sentinel Lymph Nodes in Endometrial Cancer

Official Title

A Prospective Phase 2 Study Comparing Three Injection Sites to Detect Sentinel Lymph Nodes in Endometrial Cancer: Comparison of Lymphatic Drainages and Location of the Sentinel Lymph Nodes Depending on the Injection Site of the Tracer

Brief Summary

      Uterine cancer is the most common gynecologic malignancy in developed countries.
      Adenocarcinoma of the endometrium is the most common histologic type of uterine cancer.
      Endometrial cancer is the fifth most frequent cancer in women in Switzerland. The incidence
      rose up to 5.9% in 2015. This tumor affects mainly older women, at 63 years on average. The
      majority of women are diagnosed at an early stage. Seventy-five to 90% of the patients are
      alerted by abnormal uterine bleeding very quickly, which allows a quick management of care
      and a high survival rate.

      Besides age, one of the main risk factor of developing an endometrial carcinoma is obesity.
      In fact, obese women have higher risk to have an endometrial cancer, but also at a younger
      age than the average and finally they have an increased risk of death due to this particular
      cancer. Although this cancer is linked to the co-morbidities that go with obesity like
      diabetes or hypertension.

      The treatment of endometrial cancer in most women is surgery involving a total hysterectomy
      and a bilateral salpingo-oophorectomy with or without a lymph node dissection. For patients
      with early stage endometrial cancer, there is a disagreement regarding lymph nodes
      dissection, because randomized controlled trials and a meta-analysis have shown no clear
      evidence on overall or recurrence-free survival and a higher incidence on early and late
      complications in relation with pelvic lymph node dissection. A systematic lymph node
      dissection consists of removing all the nodes within a nodal drainage basin. This dissection
      proves to be very difficult in obese patient and includes a risk to damage blood vessels or
      nerves. Moreover, lymph node dissection is associated with a higher morbidity, longer
      operating time, more frequent blood loss and finally symptomatic lymphedema and seroma.

      That is why, sentinel lymph node biopsy (SLNB) seems to be a good alternative to lymph node
      dissection. The tumor's spread is assessed in lymph nodes with a reduced morbidity. In fact,
      lymphadenectomy and its dangerous complications, like lymphedema, could be avoided in the
      vast majority of cases. Indeed, a histological analysis of these sentinel lymph-nodes (SLNs)
      leads to ultrastadification: cancers are graded depending on the presence and the size of
      metastasis in lymph nodes. Adjuvant treatments, such as radiotherapy or chemotherapy, can be
      suggested following these data and a better management of endometrial cancer is possible.
    

Detailed Description

      Worldwide, in 2012, 527'600 women were diagnosed with uterine cancer. It is the most common
      gynecologic malignancy in developed countries. In developing countries, it is the second most
      common, just behind cervical cancer. Adenocarcinoma of the endometrium is the most common
      histologic site and type of uterine cancer. Endometrial cancer is the fifth most frequent
      cancer in women in Switzerland. The incidence rose up to 5.9% in 2015. This tumor affects
      mainly older women, at 63 years on average. The majority of women are diagnosed at an early
      stage: confined to primary site for 67%, spread to regional organs and lymph nodes for 21%
      and with distant metastasis for 8%. Seventy-five to 90% of the patients are alerted by
      abnormal uterine bleeding very quickly, which allows a quick management of care and a high
      survival rate.

      Besides age, one of the main risk factor of developing an endometrial carcinoma is obesity.
      In fact, obese women have higher risk to have an endometrial cancer, but also at a younger
      age than the average and finally they have an increased risk of death due to this particular
      cancer. Although the investigators are not sure of the reasons, it may be linked to the
      co-morbidities that go with obesity like diabetes or hypertension.

      The treatment of endometrial cancer in most women is surgery involving a total hysterectomy
      and a bilateral salpingo-oophorectomy with or without a lymph node dissection. For patients
      with early stage endometrial cancer, there is a disagreement among cancer centers regarding
      lymph nodes dissection, because randomized controlled trials and a meta-analysis have shown
      no clear evidence on overall or recurrence-free survival and a higher incidence on early and
      late complications in relation with pelvic lymph node dissection. A systematic lymph node
      dissection consists of removing all the nodes within a nodal drainage basin irrespective of
      size. The problem with that technique is that dissection proves to be very difficult in obese
      patient and includes a risk to damage blood vessels or nerves.Moreover, lymph node dissection
      is associated with a higher morbidity, longer operating time, more frequent blood loss and
      finally symptomatic lymphedema and seroma. Indeed, the risk of leg lymphedema due to a node
      dissection is often under-reported, with rates going from 5% to 38%.

      That is why, sentinel lymph node biopsy (SLNB) seems to many authors to be a good alternative
      to lymph node dissection. The tumor's spread is assessed in lymph nodes with a reduced
      morbidity. In fact, lymphadenectomy and its dangerous complications, like lymphedema, could
      be avoided in the vast majority of cases. In cutaneous melanoma or in breast's cancer, this
      technique is already widely used throughout the world. A sentinel node is the first node
      involved in the movement of the tumor from the primary cancer to the lymph nodes. When tumor
      cells spread to lymphatic network, they arrive in the first place in that sentinel node. If
      it contains no metastasis, then nodes, on the lymph path below, will not be affected either.

      Not only SLNB in endometrial cancer is associated with a reduction in morbidity compared to
      lymph node dissection, but with it, a personalized treatment can be developed. Indeed, a
      histological analysis of these sentinel lymph-nodes (SLNs) leads to ultrastadification:
      cancers are graded depending on the presence and the size of metastasis in lymph nodes.
      Adjuvant treatments, such as radiotherapy or chemotherapy, can be suggested following these
      data and a better management of endometrial cancer is possible. Now, when lymph-node status
      is still unknown, indication for adjuvant therapies are based on pathological features of
      surgical specimens of the tumor, exposing some patients to either overtreatment or
      undertreatment.

      In fact, five-year disease free survival in stage I patients with positive SLNs is 54%,
      whereas survival with negative SLNs is up to 90%.Therefore, SLN is one of the most important
      prognostic factors in endometrial cancer.

      Primary objective of SENNAN study: The study seeks primarily to compare the location of
      uterine SLNs depending on the injection sites of the tracers: whether in endometrium, in
      uterine isthmus or in the cervix.

      Secondary objectives are:

        1. A comparison of the sensitivity of the tracers to detect SLNs

        2. A description of the incidence of adverse events

        3. An evaluation of additional time required to identify SLNs with or without lymph node
           dissection.

        4. A description of morbidity directly induced by the search of SLNs

        5. A calculation of negative predictive value of the different markers and their
           associations

        6. A correlation between the anatomical locations of the SLNs and ultrastadification of
           SLNs.

        7. An evaluation of the data of the lymphatic drainage, depending on tumor location in the
           uterus.

        8. An evaluation of the data of the lymphatic drainage, depending on histological grade of
           the tumor.

        9. An analysis of cases wherein change in the treatment have been made related to results
           of detection of SLNs.

      Procedure:

      The patients will have the day before the surgery an identification of the sentinel nodes
      with radiocolloid (Nanocoll®). The marker at a radioactivity of 80 MBq will be injected in
      four points in the cervix, 0.2 ml of 20 millibecquerel each. A CTscintigraphy will be
      performed three or four hours after the injection. The day of the surgery, the patients will
      undergo a general anaesthesia and then under general anaesthesia, the first step of the
      surgery will be to do the injection of the other two markers :

        -  ICG® will be injected through hysteroscopic guidance apart of the tumoral lesions at 4
           points of injections. The volume of injected ICG will be 0.5 ml at each injection at the
           concentration of 5 mg/ml. A total of 2 ml (10mg) of ICG will be used.

        -  Patent blue® will be diluted with 2 ml of physiologic serum. Then it will be injected
           through the cervix along the uterus isthmus at the 3 o'clock and 9 o'clock level. 2 ml
           will be injected on each side.

      Then the patients will have a laparoscopic surgical approach with identification of the
      sentinel nodes in the pelvic and lower abdomen areas. After identification of all the
      sentinel nodes : blue and / or radioactive and / or fluorescent nodes, the patients will have
      a total hysterectomy with bilateral oophorectomy and salpingectomy. The surgical technique
      for this procedure is the same as the one usually performed for this kind of lesions.

      The major benefit of looking for SLNs in endometrial cancer is that lymphadenectomy can be
      avoided for patients who have already comorbidities. Indeed, endometrial cancer is found in
      aged women and obese women are also more affected. Lymphadenectomy is a heavy procedure with
      a risk of lymphedema. That is why the technique of SLNs offers a good alternative with lesser
      surgical risks.
    


Study Type

Interventional


Primary Outcome

Lymphatic route of endometrial cancer dissemination

Secondary Outcome

 Sensibility/sensitivity of the tracers

Condition

Endometrial Cancer

Intervention

Lymphatic drainage of endometrial cancer

Study Arms / Comparison Groups

 Arm with procedure: identification of lymphatic drainage of the uterus following 3 sites injections
Description:  A radiocolloid (Nanocoll® marked with Technetium 99), a fluorochrome (ICG) and a blue dye (Bleu Patenté®) will be injected in submucosal tissue to see the differences in lymphatic drainage between three different injection sites. Indeed, ICG will be injected under the endometrium, whereas Nanocoll® will be injected in the cervix and Bleu Patenté® in the uterine isthmus, at the transition between the cervix and the uterine corpus.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

120

Start Date

October 19, 2020

Completion Date

December 2024

Primary Completion Date

September 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Informed Consent as documented by signature

          -  Early endometrial cancers (of International Federation of Gynecology and Obstetrics
             stage IA-IB), whatever histological grade and type

          -  Primary surgical treatment with hysterectomy

          -  No metastasis, no other cancers, no recurrency of cancers

          -  No signs of lymph nodes metastasis on the preoperative workup (MRI +/- positron
             emission computed tomography)

          -  No contraindication to laparoscopic procedures.

          -  Women of > 18 years

        Exclusion Criteria:

          -  Known severe allergies (antecedents of Quincke oedema, anaphylactic shock,…) and a
             history of allergy to iodides

          -  Contraindications to the injected products because of known hypersensitivity or
             allergy to ICG of blue dye

          -  Antecedent of pelvic lymph nodes surgery

          -  Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage
             (conisation or myomectomy)

          -  Other diagnosed cancer during treatment or care

          -  Stage II and above (tumor invading cervix stroma) including those after a neo-adjuvant
             treatment

          -  Suspicion of lymph nodes metastasis at preoperative workup

          -  Medical or uterine conservative treatment

          -  Patient, who does not understand, speak or write in French

          -  Drugs that can interfere with ICG : anti convulsants - bisulphite compounds -
             haloperidol - heroin - pethidine [meperidine] - methamizole - methadone - morphine -
             nitrofurantoin - opium alkaloids - phenobarbitone- phenylbutazone - cyclopropane -
             probenecid - rifamycin - sodium bisulphite (mostly combined with heparin)

          -  Radioactive iodine uptake performed less than one week following the use of ICG.

          -  Hypersensitivity to Nanocoll, to any of the excipients (Stannous chloride, dihydrate
             Glucose, anhydrous Poloxamer 238 Sodium phosphate, dibasic, anhydrous Sodium phytate,
             anhydrous) or to any of the components of the labelled radiopharmaceutical.

          -  A history of hypersensitivity to products containing human albumin

          -  Hypersensitivity to dyes made of triphenylmethane

          -  Lymphostasis
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Patrice Mathevet, MD - PhD, +41213146727, [email protected]



Administrative Informations


NCT ID

NCT04577950

Organization ID

SENNAN


Responsible Party

Principal Investigator

Study Sponsor

Centre Hospitalier Universitaire Vaudois


Study Sponsor

Patrice Mathevet, MD - PhD, Principal Investigator, Centre Hospitalier Universitaire Vaudois


Verification Date

October 2020