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Trial Title:
18F-AraG PET/CT as a Non-Invasive Imaging Biomarker for Chemoradiation Treatment Response in Esophageal Cancer
NCT ID:
NCT06414902
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ArabinoFuranosylGuanine [18F]F-AraG
Description:
Given by IV
Arm group label:
18F-FAraG PET
Summary:
To learn if 18F-FAraG PET scans can find tumors in participants with esophageal cancer
and predict a participant's response to treatment.
Detailed description:
Primary Objectives
- Evaluate the ability of 18F-FAraG PET imaging to detect tumors in participants with
esophageal cancer;
- Evaluate 18F-FAraG PET as a predictor of pathologic complete response
Secondary Objectives
- Evaluate the correlation of 18F-FAraG PET with clinical characteristics
- Evaluate the correlation of 18F-FAraG PET with scRNA-seq data
- Evaluate tissue and blood biomarkers as predictors of treatment response and disease
recurrence
- Evaluate functional imaging with 18F-FAraG PET and tissue and blood biomarkers as
predictors of overall survival and disease-free survival
- Compare 18F-FAraG PET SUV update to the change in standard 18FDG-PET SUV parameters
before and after chemoradiation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participants must be ≥18 years of age
2. Participants with locally advanced esophageal cancer
3. Participants with untreated documented carcinoma of the esophagus that is > 2 cm in
patients who are going to receive systemic therapy concurrently with radiation as
primary therapy are eligible
4. Ability to provide written informed consent in accordance with institutional
policies
5. Female participants of childbearing potential must have a negative serum or urine
pregnancy test within 1 week of the proposed investigational PET/CT scan(s) prior to
injection of the investigational radiopharmaceutical
6. The effects of 18F-FAraG PET on the developing human fetus are unknown. For this
reason and because 18F-FAraG PET agents as well as other therapeutic agents used in
this trial are known to be teratogenic, women of child-bearing potential and men
must agree to use adequate contraception (hormonal or barrier method of birth
control; abstinence) prior to study entry and for the duration of study
participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional
Policy # CLN1114). This includes all female participants, between the onset of
menses (as early as 8 years of age) and 55 years unless the participant presents
with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal
range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization
procedure.
7. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth
control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine
device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy,
Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging
in sexual activity for the total duration of the trial and the drug washout period
is an acceptable practice; however periodic abstinence, the rhythm method, and the
withdrawal method are not acceptable methods of birth control. Should a woman become
pregnant or suspect she is pregnant while she or her partner is participating in
this study, she should inform her treating physician immediately.
Exclusion Criteria:
1. Body weight ≥400 pounds or body habitus or disability that will not permit the
imaging protocol to be performed
2. Pregnant or lactating females - Pregnant women are excluded from this study because
18F-FAraG PET agent with the potential for teratogenic or abortifacient effects.
Because there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with [Agent], breastfeeding should be
discontinued if the mother is treated with [Agent]. These potential risks may also
apply to other agents used in this study.
3. History of allergic reaction to intravenous contrast
4. eGFR<40 within 1 month prior to receiving 8F-FAraG
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven Lin, MD
Phone:
713-563-8490
Email:
shlin@mdanderson.org
Investigator:
Last name:
Steven Lin, MD
Email:
Principal Investigator
Start date:
September 4, 2024
Completion date:
October 1, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06414902
http://www.mdanderson.org
