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Completed

NCT Number: NCT03315351

Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer

Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

The study will proceed as follow:

  • Initial check-up before the brachytherapy, including a clinical exam, collect of disease history and other informations that can be required for a good execution of the trial, and a usual patient care (chemotherapy with concomitant radiotherapy, biopsy, RMI, PET-scan and paraaortic lymphadenectomy).
  • additional PET-scan exam at day 1 of the brachytherapy (with collect of informations on toxicity, clinical morphology data and biomorphological data of RMI and PET-scan, and dosimetric study of the brachytherapy)
  • 4 months after the brachytherapy, additional PET-scan monitoring metabolic volumes and standardized metabolic fixation parameters

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient suffering from a cervical cancer:
  • squamous-cell carcinoma or adenocarcinoma histologically proven
  • classified from FIGO 2009 IB2 to IVA stage
  • Age ≥ 18 years old
  • Examination by PET-scan and pelvic RMI realized at diagnosis
  • Examination by negative PET-scan remotely closed and at lymph node level
  • Surgical lymphadenectomy negative at paraaortic level
  • Treatment by external radiotherapy (doses between 45 Gy and 50.4 Gy in 1.8 Gy/fractions) and concomitant chemotherapy (at least 4 cures per weeks using platinum salt) done
  • Scheduled curative treatment by brachytherapy driven by RMI
  • Affiliation to the National Social Security System
  • With informed and signed consent before any procedure specific to the study

Exclusion criteria

  • Performance status of WHO score > 2
  • Other histology than squamous cell carcinoma or adenocarcinoma
  • Metastatic patient or paraaortic node positive
  • Adjuvant radiochemotherapy after the first surgery
  • Dementia or psychiatric history
  • Kidney failure
  • Diabet
  • Chronic inflammatory bowel disease
  • Pelvic and/or vesicoureteral surgery history
  • Pelvic irradiation history
  • Other active neoplasia or < 5 years old, except for basocellular carcinoma that can be locally treated
  • Contraindication to one of the following procedure : RMI, PET-scan, general anesthesia
  • Radiosensitive disease (Fragile X syndrome, Huntington's chorea, Xeroderma Pigmentosum, connective tissue disease) or signs of radiosensitivity.
  • Treatment with palliative intent
  • Pregnant or breastfeeding women
  • Patient Under guardianship or tutorship

Treatment and study plan

Brachytherapy

Procedure

Before it starts, a consultation will be done to collect patient's informations and disease history, a clinical exam will be done and an evaluation of radio-chemotherapy toxicity will be realized.

The brachytherapy include a pulsating flow treatment driven by RMI and CT-scan

PET-scan

Other

The patient will undergo 2 PET-scan during the clinical trial:

  • the first one is additional to the brachytherapy
  • the second one is realized 4 months after the brachytherapy

Primary outcomes

  1. Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams

    Time frame: 4 months

    Concerning this outcome, the success in terms of feasibility will be the possibility of realizing the TEP-Curie exam

  2. Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the possibility to define HR-CTV target volume (High-Risk Clinical Target Volume)

    Time frame: 4 months

    Concerning this outcome, the success in terms of feasibility will be the possibility of defining a HR-CTV target volume for at least one of the 3 proposed approaches using the PET

  3. Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the dicom medical image transfer

    Time frame: 4 months

    Concerning this outcome, the success in terms of feasibility will be the possibility of transfering image in a Dicom format

  4. Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the contouring possibility

    Time frame: 4 months

    Using the possibility of defining the contouring for at least one of the 3 alternative treatment plans

Secondary outcomes

  1. Impact of the "TEP-Curie" (Brachytherapy driven by PET-scan) on target volume definition

    Time frame: 4 months

    Comparison of the target volume obtained with TEP-curie to the target volume defined by the RMI alone

  2. Assessment of the HR-CTV coverage

    Time frame: 4 months

    Comparison of the HR-CTV obtained with TEP-curie to the HR-CTV obtained by the RMI alone

  3. Assessment of the dose received by the neighboring target organs

    Time frame: 4 months

    Comparison of the dose obtained with TEP-curie to the dose obtained by the RMI alone

  4. Time needed to design the different alternative treatment plans

    Time frame: 4 months

  5. Toxicity linked to the standard treatment driven by RMI only

    Time frame: 4 months

    Graded according to the NCI CTCAE v4. scale

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

Feasibility of PET-scan Carried Out at Day 1 of Brachytherapy for Patients With Locally Advanced Cervical Cancer Treated Initially by Concomitant Radio-chemotherapy

Acronym: TEP-Curie

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 20, 2017
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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