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EndometriosisNCT06377553

PET/MRI for Evaluation of Endometriosis

An observational study of Endometriosis and Endometrioma, run by Massachusetts General Hospital at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study aims to determine if PET/MRI can detect endometriosis and potentially improve upon currently available non-invasive diagnostic capabilities. Specifically, the authors will investigate the ability of PET/MRI to detect and quantify endometriosis, as well as differentiate among subcategories such as… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Endometriosis, Endometrioma
What is being tested?
Radiotracer Injection, Imaging and Rectal Ultrasound Gel Injection
Type of treatment
Injection or infusion
How many people
60 participants
Where
1 siteUnited States
Study dates
6 Jan 2025to 3 May 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 70 years
  • Women only
  • Adult, Older adult

Study population: In total, 60 subjects with clinically diagnosed endometriosis will be recruited. All subjects recruited for the study will be able to withdraw from the study at any time. The patients will be referred to the study by their treating physicians to investigate clinically diagnosed endometriosis. We will not recruit or enroll healthy volunteers in this study.

Who may be able to join

  • Patients with clinical diagnosis of endometriosis, in any stage, candidate for diagnostic overtherapeutic laparoscopic surgery.

Who cannot join

  • Subjects less than 18 years of age or greater than 70 years of age.
  • Any contraindication to MRI, including electrical implants, such as cardiac pacemakers or perfusion pumps. MRI non-compatible ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, prosthetic heart valves that are not compatible with the gradient maps of our scanners, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, and/or ferromagnetic objects such as jewelry, or metal clips in clothing that cannot be removed.
  • History of claustrophobic reactions.
  • Individuals who do not speak or understand English since providing a translated version of the entire consent form is not practicable
  • Any contraindication to PET including active breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required on the day of the scan before the subject can participate)
  • History of research-related radiation exposure exceeding current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months).
Show all 16Show fewer
  • QTc>460msec obtained within 30 days from the PET/MR
  • eGFR <60mL/min/1.73m2 obtained within 30 days from the PET/MR
  • AST >40U/L and/or ALT >55 U/L obtained within 30 days from the PET/MR
  • A greater risk than normal for potential cardiac arrest such as history of non compensated congestive heart failure, poorly controlled arrythmias, symptomatic non compensated cardiopathies.
  • History of major head trauma (i.e., multiple concussions, traumatic brain injury).
  • History of bleeding disorders.
  • Inability to lie comfortably on a bed inside the PET/MRI bore as assessed by physical examination and medical history (e.g., back pain, severe arthritis).
  • Subjects under the direct supervision of the principal investigator.
  • Body weight of > 300 lbs. (weight limit of the MRI table) or BMI >33.0 per the standard operating procedure of PET/MRI safety at the Martinos Center.
  • Subjects from any other at-risk populations (e.g., children and minors cognitively impaired persons, prisoners).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School

    Charlestown, Massachusetts, 02129

Other trials in United States

About this study

Official title: PET/MRI Evaluation of Endometriosis Using Intercellular Matrix Radiopharmaceuticals

This study aims to determine if PET/MRI can detect endometriosis and potentially improve upon currently available non-invasive diagnostic capabilities. Specifically, the authors will investigate the ability of PET/MRI to detect and quantify endometriosis, as well as differentiate among subcategories such as inflammatory peritoneal lesions, fibrotic deep infiltrating endometriosis lesions (DIE), and ovarian endometriomas. The authors will compare [68Ga]CBP8 or [18F]-FAPI-74 PET/MRI imaging versus the current gold standard diagnostic methods, including laparoscopic surgery, clinical follow-up, and follow-up imaging.

Read the detailed description

Several imaging techniques, including ultrasound, computed tomography and magnetic resonance imaging (MRI), have been used for the detection of DIE, for mapping and staging endometriosis. Currently, the modalities most commonly used are transvaginal ultrasound (TVS) and magnetic resonance imaging MRI. TVS is generally considered a first-line technique.TVS, in highly experienced hands, meets the criteria for mapping DIE to the uterosacral ligaments, rectovaginal septum, vaginal wall, pouch of Douglas and rectosigmoid; however it is limited by its operator dependance and by the small field of view (FOV). MRI is commonly used for mapping lesions within the Douglas pouch and rectovaginal septum and rectosigmoid. MRI has shown acceptable diagnostic values, with pooled sensitivity and specificity for pelvic endometriosis of 94% and 77%, respectively. For rectosigmoid endometriosis, MRI's pooled sensitivity and specificity were 92% and 96%, respectively. However, MRI has limitations, specially in the evaluation of chronic fibrotic endometriosis and for assessing the peritoneum and extension beyond the pelvis as well as DIEs. There is a growing body of literature examining the role of PET/MRI in pelvic and abdominal malignancies and its potential superiority to MRI alone. However, there are no studies that used PET/MRI to investigate endometriosis.

This study aims to use [68Ga]CBP8- or [18F]FAPI PET/MRI to diagnose and quantify endometriosis. The novel radiopharmaceutical collagen-binding probe 8 labeled with Gallium-68 selectively binds to collagen type I, the predominant extracellular protein in fibrosis. [68Ga]CBP8 has already been investigated in patients affected by pulmonary fibrosis with success. Fibroblast activation protein (FAP) is a type II transmembrane serine protease that is overexpressed in CAFs and, to a lesser extent, in benign processes. It is associated with extracellular matrix remodeling, for example, chronic inflammation, degenerative bone and spine disease, arthritis, and cardiac remodelling after myocardial infarction. Quinolone-based FAP inhibitors (FAPIs) constitute a class of molecules with high affinity to FAP deployed to assess many types of solid tumors and some benign pathologies. 68Ga-FAPIs and, to a lesser extent, 18F-FAPI are being extensively studied in oncologic and non-oncologic positron emission tomography/computed tomography (PET/CT) and, to a lesser extent, PET/MRI, both in Europe and Asia.

In this single-arm, single-center, open label prospective study, the authors will recruit 60 patients with clinical diagnosis of endometriosis who candidate for laparoscopic surgery. Patients will be referred to FAPI- or CBP8-PET/MRI by their primary treating gynecologist physicians. Laparoscopy will serve as primary standard of reference; clinical and imaging follow up, as well as prior diagnostic imaging studies (CT, MRI, US), will serve as secondary standard of reference. In the case patients will not undergo laparoscopy, then clinical and imaging follow up, as well as prior diagnostic imaging studies (CT, MRI, US), will serve as primary standard of reference.

Board-certified radiologists will evaluate [18F]-FAPI-74 or [68Ga]CBP8-PET/MR images and standalone MR images in a blinded fashion on separate occasions. Assessment of of endometriosis will be performed according to consolidated published criteria for MRI. For endometriosis staging, the readers will follow rASRM criteria. Then, the authors will compare the sensitivity, specificity, and accuracy of regional/whole-body staging using FAPIor CBP-PET/MRI versus regional/wholebody MRI, with the standard reference set as pathology results, when available, or clinical and imaging follow-up otherwise. Hypothesis testing will be performed using McNemar's test for matched pairs testing.

Being tested
Radiotracer Injection, Imaging, Rectal Ultrasound Gel Injection
Keywords
Endometriosis, [18F]-FAPI-74, [68Ga]CBP8-PET, PET/MR, Fibrosis, DIE, Endometrioma
Medical subject headings
Endometriosis, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotracer InjectionDrug

    An intravenous catheter will be placed in an arm or hand vein for injection of [68Ga]CBP8;

    6-10 mCi of [68Ga]CBP8 or 5-9 mCi of FAPI will be injected into the Biograph mMR system. The injected dose and the time of injection will be recorded; The catheter will be flushed with 0.9% saline solution; The subjects will then be positioned on the scanner table; support devices under the back or legs will be used to enable the patient to maintain his/her position throughout the scan comfortably.

  • ImagingDiagnostic test

    MRI and PET scanner to be used:

    3.0 T Laboratory (Bay 7) Siemens Biograph mMR.

    Magnetic resonance images of the pelvis and abdomen will be acquired using the Martinos Center's combined 3 Tesla PET/MRI scanner. The image quality on these 3 Tesla devices will be very high, equivalent to or better than any other standard clinical MRI system. PET images of the target body site will be acquired when necessary, the data acquisition will be started shortly before radiotracer injection; Coincidence event data will be acquired and stored in list mode or compressed (i.e., sinogram space) format. Subjects will be asked to lie still for the duration of the study. The entire imaging session will last up to 120 minutes

  • Rectal Ultrasound Gel InjectionOther

    About 50ml of ultrasound gel will be placed into the vagina using the blunt end of the ultrasound gel tube or a Foley catheter or a syringe with a blunt Christmas tree end. No ultrasound probe will be inserted into the vagina, no external ultrasound probe will be used. No ultrasound study will be performed. The ultrasound gel will only be used to distend the vagina and improve the quality of MRI images; this is standard of practice in MRI for endometriosis and for several other gynecological diseases.

Study groups in NCT06377553
Study groupRoleWhat they receive
EndometriosisPatient with clinical diagnosis of endometriosis, in any stage, candidate for diagnostic or therapeutic laparoscopic surgery.
Receives: Drug: Radiotracer Injection; Diagnostic Test: Imaging; Other: Rectal Ultrasound Gel Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic Accuracy of PET/MR in Preoperative Endometriosis Detection

    To determine the accuracy, sensitivity, and specificity of [18F]-FAPI-74 and/or [68Ga]CBP8 PET/MRI in detecting and classifying endometriosis, using the gold standard methods as the reference.

    Measured: 1-2 Months

  2. Diagnostic Performance of PET/MRI vs. Conventional Imaging

    To determine the accuracy, sensitivity, and specificity of [18F]-FAPI-74 or [68Ga]CBP8-PET/MR images versus stand-alone wholebody MRI and/or pelvic MRI and/or ultrasound and/or computed tomography in pre-operative patients with suspected endometriosis lesion.

    Measured: 1-2 Months

Secondary outcomes (2)

  1. Impact of [18F]-FAPI-74 and [68Ga]CBP8 PET/MRI on Diagnosis and Management in Endometriosis

    To determine if imaging with [18F]-FAPI-74 and/or [68Ga]CBP8 PET/MRI results in changes to diagnosis, medical or surgical management in endometriosis patients

    Measured: 1-6 months

  2. Correlation of Pre-Treatment PET Uptake and Post-Treatment Response in Endometriosis

    To determine if pre-treatment measures of [18F]-FAPI-74 and/or [68Ga]CBP8 standardized uptake values (SUVs) are correlated to post-treatment response in patients with endometriosis.

    Measured: 6-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study start6 Jan 2025
  3. Primary completion3 Jan 2028 (estimated)
  4. Study completion3 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06377553
Sponsor's protocol ID
2023P000955
Status last verified
Mar 2026
First submitted
17 Apr 2024
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Taylor HS, Kotlyar AM, Flores VA. Endometriosis is a chronic systemic disease: clinical challenges and novel innovations. Lancet. 2021 Feb 27;397(10276):839-852. doi: 10.1016/S0140-6736(21)00389-5.

    PubMed 33640070

  • Moradi Y, Shams-Beyranvand M, Khateri S, Gharahjeh S, Tehrani S, Varse F, Tiyuri A, Najmi Z. A systematic review on the prevalence of endometriosis in women. Indian J Med Res. 2021 Mar;154(3):446-454. doi: 10.4103/ijmr.IJMR_817_18.

    PubMed 35345070

  • Bazot M, Darai E. Diagnosis of deep endometriosis: clinical examination, ultrasonography, magnetic resonance imaging, and other techniques. Fertil Steril. 2017 Dec;108(6):886-894. doi: 10.1016/j.fertnstert.2017.10.026.

    PubMed 29202963

  • Nisenblat V, Bossuyt PM, Farquhar C, Johnson N, Hull ML. Imaging modalities for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2016 Feb 26;2(2):CD009591. doi: 10.1002/14651858.CD009591.pub2.

    PubMed 26919512

  • Saba L, Sulcis R, Melis GB, Ibba G, Alcazar JL, Piga M, Guerriero S. Diagnostic confidence analysis in the magnetic resonance imaging of ovarian and deep endometriosis: comparison with surgical results. Eur Radiol. 2014 Feb;24(2):335-43. doi: 10.1007/s00330-013-3013-9. Epub 2013 Sep 12.

    PubMed 24026621

  • Giesel FL, Adeberg S, Syed M, Lindner T, Jimenez-Franco LD, Mavriopoulou E, Staudinger F, Tonndorf-Martini E, Regnery S, Rieken S, El Shafie R, Rohrich M, Flechsig P, Kluge A, Altmann A, Debus J, Haberkorn U, Kratochwil C. FAPI-74 PET/CT Using Either 18F-AlF or Cold-Kit 68Ga Labeling: Biodistribution, Radiation Dosimetry, and Tumor Delineation in Lung Cancer Patients. J Nucl Med. 2021 Feb;62(2):201-207. doi: 10.2967/jnumed.120.245084. Epub 2020 Jun 26.

    PubMed 32591493

  • Hamson EJ, Keane FM, Tholen S, Schilling O, Gorrell MD. Understanding fibroblast activation protein (FAP): substrates, activities, expression and targeting for cancer therapy. Proteomics Clin Appl. 2014 Jun;8(5-6):454-63. doi: 10.1002/prca.201300095. Epub 2014 Mar 24.

    PubMed 24470260

  • Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696.

    PubMed 28381537

  • Giesel FL, Kratochwil C, Lindner T, Marschalek MM, Loktev A, Lehnert W, Debus J, Jager D, Flechsig P, Altmann A, Mier W, Haberkorn U. 68Ga-FAPI PET/CT: Biodistribution and Preliminary Dosimetry Estimate of 2 DOTA-Containing FAP-Targeting Agents in Patients with Various Cancers. J Nucl Med. 2019 Mar;60(3):386-392. doi: 10.2967/jnumed.118.215913. Epub 2018 Aug 2.

    PubMed 30072500

  • Blandino AA, Caravan P, Shenoy-Bhangle AS, Quiros E, Russo MV, Misialek MJ, Domachevsky L, Tsai LL, Catalano OA. Collagen-binding (6)(8)Ga-CBP8 PET/MR in Deep Pelvic Endometriosis: First-in-human Application. Mol Imaging Biol. 2026 Jul 14. doi: 10.1007/s11307-026-02125-5. Online ahead of print.

    PubMed 42449010

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis and Endometrioma, run by Massachusetts General Hospital at 1 site in United States.

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 1 inclusion and 16 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: enrolling by invitation, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Accuracy of PET/MR in Preoperative Endometriosis Detection (time frame: 1-2 Months). The study lists 2 primary outcomes in all. 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 NCT06377553, which also lists 10 linked publications.

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 12 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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