A Phase 2 interventional study of FDG PET scan in Cancer of the Cervix, Vulvar Cancer and Esophageal Cancer, sponsored by Duke University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 17 studies in Uterine Cervical Neoplasms by Duke University — 5 open to participants now, 6 under way, none of them phase 3. Uterine Cervical Neoplasms · Duke University.
Among the 17 studies in Uterine Cervical Neoplasms by Duke University, this one is the 11th largest by enrollment of the 15 interventional ones that give a count, is the only one that started in 2018, is the only one in phase 2, and was the 9th registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
Browse Uterine Cervical Neoplasms studies →5 of the 17 studies in Uterine Cervical Neoplasms by Duke University are open now, in 2 countries. Recruiting first, the newest first:
Duke University · Sites in Kenya
Ages 18+ · Healthy volunteers
Duke University · Sites in Kenya
Ages 25+ · Women only
Duke University · Sites in United States
Ages 21–65 · Women only · Healthy volunteers
Duke University · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Duke University
Ages 18+ · Women only
By country, each count listing its studies:
Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2018.
This study's enrollment of 90 is close to the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Median enrollment 284 across the 15 interventional studies, 196 across the 2 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
2 of the studies in Uterine Cervical Neoplasms by Duke University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06458062Duke UniversityPocket Colposcopy Using CARE Algorithm | 2027-04-30 |
| NCT05848557Duke UniversitymSaada: A Mobile Health Tool | 2027-06-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 17 studies in Uterine Cervical Neoplasms by Duke University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study expands on protocol (NCT01908504"PET adaptive RT") designed to evaluate the utility of adaptive PET-CT planning for radiation therapy (RT). Radiation therapy is used in many malignant diseases as a curative treatment modality. However, critical normal tissue is often in close approximation to disease, and portions of such tissue must receive high doses of radiation for appropriate treatment.
Positron Emission Tomography (PET) adapted radiation therapy, as defined in the current protocol, may allow for a means of determining the eventual response to therapy, at a time point when adaptation of treatment plan may be possible to improve outcomes. This protocol will build upon the findings the previous protocol (NCT01908504 "PET adaptive RT") that evaluated the utility of intra-treatment PET imaging in multiple types of cancers. The current focus will be more specific to certain types of gastrointestinal and gynecologic cancers treated with RT, identified from the prior study to warrant further research.
Intra-treatment PETs have only recently been studied in small pilot series. In rectal cancer, a prospective trial from MSKCC demonstrated that a PET-CT obtained in the second week of neoadjuvant chemoradiotherapy was able to discriminate sub-optimal responders with a sensitivity of 94% and an accuracy of 78%, though the most useful metric was a novel "visual response score" based on interpreting radiologists scoring rather than more established objective data available from PET, like SUV. A study from China in non-small cell lung cancer found that decreases in SUV and MTV on intra-treatment PET-CTs after 40Gy of chemoradiation therapy were significantly greater in patients responding to treatment by post-treatment RECIST criteria. For head and neck cancers, a Belgian study found that intra-treatment SUVmax at 47Gy was associated with significant differences in overall survival. Therefore, there is emerging evidence that an intra-treatment PET may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly.
All participants will be required to complete two research PET scans in addition to standard of care planning CT's for radiation therapy. For all subjects with cancer of the cervix and vulva an intra-treatment PET-CT will be obtained and used to develop a volume adaptive treatment plan for the remainder of the course. Subjects with esophageal and anal canal cancer will have an adapted plan if the treating radiation oncologist determines an adapted plan is clinically relevant.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pathologically (histologically or cytologically) proven diagnosis of cervical, vulvar, esophageal and anal canal cancer
Patients with local or regional nodal disease are eligible
Zubrod Performance Status 0, 1, or 2
Age ≥ 18
Negative serum pregnancy test for women of child bearing potential
Patient must sign study-specific prior to study entry
Exclusion Criteria:
No gross disease visible on imaging at the start of radiotherapy
to PET
Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy)
Breast feeding
Positive serum pregnancy test
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Research FDG-PET scan obtained before radiation therapy; a second research FDG-PET scan is obtained at about 3-5 weeks after treatment has started.
Other: FDG PET scan
At radiation planning subjects will have a PET-CT. The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.
Also known as: PET scan
The number of subjects with benefit from an intra-treatment PET-CT
This benefit lies in the potential to adapt the treatment plan based on an intratreatment PET-CT. This may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly
Time frame: 4 years
Pathologic complete response
Pathologic complete response will be collected from pathology reports for subjects who have surgical resection after radiation therapy.
Time frame: 4 years
Locoregional control
This study will evaluate the prognostic value of intra-treatment functional imaging on clinical relevant tumor endpoints (i.e. locoregional control, freedom from distant metastases, and overall survival).Comparison of intra-treatment FDG-PET indices will identify two groups of responses: PET responses and PET non-responses, which will correlate with prognosis.
Time frame: Day of intra treatment PET-CT/ approx 2-4 hours
Freedom from distant metastases
Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care, or at the treating investigator's discretion. Frequency of follow up will be determined by the standard practice for the disease site and stage.
Time frame: 4 years
Measure overall survival (OS)
Subjects will be evaluated in regular follow up with the investigators according to the standard of care for each disease site
Time frame: 4 years
Progression free survival (PFS)
Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care for each disease site
Time frame: 4 years
Measure the potential sparing of radiation dose to critical normal tissue
An intra-treatment PET volume adaptive treatment plan may allow for additional sparing of normal tissue by identifying regions of tumor response and corresponding reduction in the target volumes i.e. dosimetric differences in normal tissue will be compared between the initial plan and the adapted plan.
Time frame: 4 years
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2018 (actual). Primary completion is estimated for Apr 2028, 120 months after the start.
Of 154 non-industry phase 2 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 99. This study's planned 120 months is above that.
Counting every sponsor, half of 204 studies reached it within 42 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.