Image-Guided Gynecologic Brachytherapy

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id: NCT01399658
trial label: Image-Guided Gynecologic Brachytherapy
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 1
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT01399658
outcome key
om-0000
source section id
NCT01399658-om-0000
source outcome index
0
endpoint
Mean Doses Given
endpoint definition
Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.
time origin
Measured while on treatment, up to 2 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT01399658
outcome key
om-0000
arm key
OG000
arm label
Image-Guided Brachytherapy
regimen
Image-guided brachytherapy Image-guided brachytherapy: MRI-guided application of brachytherapy 3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer
analyzed count
84
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01399658-om-0000#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-keytruda-qlex-d7d2e489
nct id
NCT01399658
harm key
EG000
source section id
NCT01399658-ae
event group key
EG000
event group label
Image-Guided Brachytherapy
serious affected
0
serious at risk
93
other affected
86
other at risk
93
frequency threshold
0
collection period
From registration to 90 days post-procedure, up to 15 months.
event definition
Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice