Glow-in-the-dark dye may help surgeons spot sarcoma during removal
NCT ID NCT07038278
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This early-stage study tests whether a fluorescent dye called 5-ALA can make soft-tissue sarcoma tumors glow during surgery, helping surgeons see the edges more clearly. About 20 adults with grade 2 or 3 sarcoma will take the dye by mouth before their standard surgery. The main goal is to see if the dye lights up the tumor and helps distinguish it from healthy tissue, not to cure or control the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histological confirmation of any subtype of primary Grades 2 or 3 soft tissue sarcomas (STS), per biopsy evaluation by a pathologist, according to Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC). 2. Treatment decision includes planned surgical resection of STS. 3. Age ≥18 years at time of consent. 4. ECOG Performance Status 0 - 1. 5. Hematology and blood chemistry parameters defined by: 1. Leukocytes ≥ 3 × 10(9)/L 2. Absolute neutrophil count ≥ 1.5 × 10(9)/L 3. Platelets ≥ 100 × 109/L, transfusions may be used to raise platelets to ≥ 100 × 10(9)/L (no washout required) 4. Hemoglobin ≥ 9 g/dL, transfusions may be used to raise Hgb to ≥ 9 g/dL (no washout required) 5. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) 6. Aspartate transaminase (AST) / alanine transaminase (ALT) ≤ 2.5 × institutional ULN 7. Creatinine within normal institutional limits OR creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine above institutional ULN 6. Participants of reproductive potential must agree to using adequate contraception (e.g., hormonal or barrier method of birth control; abstinence, an intrauterine device) for the duration of study participation (including dosing interruptions) and up to 42 days after end of study intervention; or be surgically sterilized (e.g., hysterectomy, tubal ligation, or vasectomy). 7. Ability to swallow study agent. 8. Ability to understand and willingness to sign an informed consent form. 9. Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study. Inclusion of Minorities and Other Underrepresented Populations Recruitment is open and encouraged to all genders, all minorities, and underrepresented populations. Although distributions may vary by disease type, our recruitment procedures have been developed to enroll participants who are representative of the respective target population. Exclusion Criteria: 1. Acute/chronic forms of porphyria. 2. Uncontrolled, known concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness. 3. Patient has had chemotherapy, tumor resection, or radiation treatment ≤ 21 days prior to surgery. 4. Simultaneous participation in another clinical trial ≤ 21 days of enrollment or during the duration of the study period. 5. Planned use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones and tetracyclines), and topical preparations containing aminolevulinic acid (5-ALA) for 24 hours during the perioperative period (defined as 24 hours prior to surgery to up to 24 hours post-surgery). 6. Pregnant or planning to become pregnant during study participation or breastfeeding. 7. Any condition that is in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Colorado Hospital
Aurora, Colorado, 80045, United States
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Other studies related to the condition(s) this trial covers.
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- Can a smart drug hunt down sarcoma cells without harming healthy ones?
- Can a Patient's own immune cells fight advanced sarcoma?
- Smartwatch exercise plan aims to rebuild fitness in young cancer survivors
- Can tailored exercise help young sarcoma survivors recover strength?